FDA Adverse Event
Malfunction
Summary report: N
BIOPSY SUTURE
MDR report key: 20149843
·
Received September 5, 2024
Report
- Report Number
- 3012164473-2024-00006
- Event Type
- Malfunction
- Date Received
- September 5, 2024
- Date of Event
- September 5, 2024
- Report Date
- August 16, 2024
- Manufacturer
- CP MEDICAL
- Product Code
- GAR
- UDI-DI
- 10790986006499
- PMA / PMN Number
- K001173
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
A COMPLAINT WAS RECEIVED REGARDING LOT 210302-51, SIZE 4/0 NYL BLA. ACCORDING TO THE CUSTOMER COMPLAINT, THE SUTURE WAS NOT ATTACHED TO THE NEEDLE. NO INJURIES OR DELAY IN THE SURGICAL PROCEDURE WAS REPORTED BY THE CLINIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2268030 | BIOPSY SUTURE | SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE | GAR | CP MEDICAL | 931B-DEL | 210302-51 | 10790986006499 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |