FDA Adverse Event
Malfunction
Summary report: N
PGA
MDR report key: 9214956
·
Received October 21, 2019
Report
- Report Number
- 3012164473-2019-00028
- Event Type
- Malfunction
- Date Received
- October 21, 2019
- Report Date
- October 16, 2019
- Manufacturer
- CP MEDICAL
- Product Code
- GAM
- UDI-DI
- 10790986000657
- PMA / PMN Number
- K002190
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
RECORD REPRESENT 3:3 PATIENTS INVOLVED WITH ISSUE SAMPLE. THERE IS A PENDING VOLUNTARILY ELECTED RECALL FOR LOT# 190123-59 DUE TO ITS FAILURE TO MEET USP TENSILE STRENGTH SPECIFICATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT SIZE 4/0 POLYGLYCOLIC ACID SUTURE SNAPPED EASILY AND KNOTS WERE NOT HOLDING. (LOT# 190123-59) THREE PATIENTS SUBSEQUENTLY EXPERIENCED DEHISCENCE OF WOUNDS. THE CLINIC HAS BEEN CONTACTED MULTIPLE TIMES IN ATTEMPT TO RETRIEVE INFORMATION REGARDING EACH PATIENT'S EVENT. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1010712 | PGA | POLYGLYCOLIC ACID ABSORBABLE SYNTHETIC SUTURE | GAM | CP MEDICAL | 494A | 190123-59 | 10790986000657 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |