DEFLUX INJECTABLE GEL
Report
- Report Number
- 3014909464-2024-00022
- Event Type
- Malfunction
- Date Received
- October 7, 2024
- Date of Event
- September 20, 2024
- Report Date
- September 25, 2024
- Manufacturer
- PALETTE LIFE SCIENCES
- Product Code
- LNM
- UDI-DI
- 00850004725009
- PMA / PMN Number
- P000029
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN#(B)(4). N/A OTHER REMARKS: CORRECTED DATA:
QN# (B)(4). COMPLAINT EVALUATION TESTING WAS PERFORMED FROM THE SAMPLE RETURNED. ONE APPROXIMATELY HALF-FULL SYRINGE WAS RETURNED, AND THE LOT NUMBER IS IN ACCORDANCE WITH THE REPORT. IT WAS OBSERVED THE SYRINGE FLANGE WAS BROKEN. THERE ARE NO DEVIATIONS OR REMARKS IDENTIFIED IN THE REVIEW OF BATCH RECORDS ON THE REPORTED LOT THAT CAN EXPLAIN THE COMPLAINT. NO QUALITY ISSUES WERE FOUND CONNECTED TO THE RAW MATERIAL (GLASS SYRINGE) WHICH CAN EXPLAIN THE COMPLAINT. THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. NO FURTHER ACTIONS WILL BE TAKEN REGARDING THIS COMPLAINT. PALETTE LIFE SCIENCES WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. OTHER REMARKS: N/A. CORRECTED DATA: N/A.
ON 25-SEP-2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION OF THE FOLLOWING EVENT FROM THE [DISTRIBUTOR], WHO RECEIVED IT FROM A [ HOSPITAL] IN SPAIN "DURING INJECTION, THE WINGS OF THE SYRINGE BROKEN".
ON 25-SEP-2024 PALETTE LIFE SCIENCES RECEIVED A NOTIFICATION OF THE FOLLOWING EVENT FROM THE [DISTRIBUTOR], WHO RECEIVED IT FROM A [ HOSPITAL] IN SPAIN "DURING INJECTION, THE WINGS OF THE SYRINGE BROKEN".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 216972 | DEFLUX INJECTABLE GEL | AGENT, BULKING, INJECTABLE FOR GASTR | LNM | PALETTE LIFE SCIENCES | 21919-1 | 00850004725009 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NONE REPORTED.| NONE REPORTED. |