FDA Adverse Event
Injury
Summary report: N
NA
MDR report key: 4374689
·
Received December 4, 2014
Report
- Report Number
- 3005180920-2014-00170
- Event Type
- Injury
- Date Received
- December 4, 2014
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LZO
- PMA / PMN Number
- K103352
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: VERSAFITCUP CC HIGHCROSS PE LINER: REF. 01.26.3648HCT / LOT 142649 ((B)(4) LINERS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) LINERS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. VERSAFITCUP CC TRIO NO HOLES SHELL (K122911): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDING WASHING AND STERILIZATION PROCEDURES. (B)(4) SHELLS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
IMP REF # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 785591 | NA | LZO | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |