OptiMed - Complaint incident report

The optimal supply
to physicians - worldwide

Our products are available in
more than 40 countries.

Complaint Incident Report

General information about the complaint
Date incident occured:
Hospital
Department
Address:
Contact person for complaint:
Hospital Phone No.:
Facsimile No.:
Mail:
Product No.:
Lot No.:
Product Description:
Quantity:
Description of event(s):
Is sample being returned:
Yes No
Why not?
Sample is:
actual complaint sample from same lot other
If other please descripe why
When did the problem occur?
after removing product from packaging during preparation for intervention during application in or on a patient
Was the patient injured by device?
Yes No
Was medical / surgical intervention required?
Yes No
Describe patient status and type of intervetions required:
Was medication administrated prior to intervention?
Yes No
Vascular Intervention
Type of procedure:
Technique:
Access
iliacal femoral transbrachial other
Where was the stent released?
Distinctive features / anomalies:
Was the stent repositioned?
Yes No
Was the swivel nut of the Y-adapter opened?
Yes No
Was the delivery system closed prior to removal?
Yes No
During the procedure was the treatment area with a ballon?
pre-dilated post-dilated
Was a contrast medium used as described in the instruction for use?
Yes No
If Yes, mixing ratio:
Diameter of Guide wire:
Coating of Guide wire:
hydrophilic other coatings
Which other coating are used:
If hydrophilic coating
flushed not flushed
Working pressure of the balloon (bar)
Urology / Gastroenterology
Type of procedure:
Technique:
Distinctive features / anomalies:
Was this the first time the product was used?
Yes No
Diameter of Guide wire:
Coating of guide wire:
hydrophilic other coatings
Other coating:
If hydrophilic:
flushed not flushed
Vertebroplasty
Indication:
Osteoporosis Metastasis Haemangioma
Name of cement used?
Time between preparation and start of cement application?
Storage temperature of cement (°C):
Room temperature during intervention (°C):
Distinctive features / anomalies:
For all areas of application
Which additional medical accessories were used during the intervention, e.g. sheaths? Please attach Manufacturer/dimension/diameter!!
Was the complaint product resterilized (sterilized twice) prior to the intervention?*
Yes No
I accept General Terms and Conditions of OptiMed.*

The optimal supply to physicians - worldwide

Products & Technology

Complaint Incident Report

General information about the complaint

Vascular Intervention

Urology / Gastroenterology

Vertebroplasty

For all areas of application

The optimal supply
to physicians - worldwide