FDA Adverse Event
Other
Summary report: N
GENEX
MDR report key: 3204682
·
Received June 28, 2013
Report
- Report Number
- 9617083-2013-00010
- Event Type
- Other
- Date Received
- June 28, 2013
- Report Date
- June 27, 2013
- Manufacturer
- BIOCOMPOSITES LTD.
- Product Code
- MQV
- PMA / PMN Number
- K082381
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ALTHOUGH THE PATIENT HAD NO SIGNS OF ADVERSE REACTION, THE PRODUCT WAS EXPLANTED AND SENT FOR MICROBIOLOGICAL ANALYSIS. BIOCOMPOSITES STIMULAN RAPID CURE WAS THEN USED TO COMPLETE THE PROCEDURE.
Description of Event or Problem · 1
REPORTED TO THE MFR THAT A PATIENT BEING TREATED IN (B)(6) HAD BEEN PROVIDED WITH A 'DEMO ONLY' PACK FOR INTEREST. THE PACK HAD BEEN HANDED BY THE PATIENT TO THE SURGEON, WHO IMPLANTED THE PRODUCT RATHER THAN THE STERILE PRODUCT PROVIDED BY THE SALES REPRESENTATIVE IN (B)(6) .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 295025 | GENEX | GENEX | MQV | BIOCOMPOSITES LTD. | NOT CONFIRMED | NOT CONFIRMED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |