N
Patient 1
IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.
MAUDE MDR 9907998
- MDR report key
- 9907998
- Report number
- 3003639970-2020-00177
- Event key
- 0
- Event type
- 3
- Date received
- 2020-03-31
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 100
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS SILVIA ORUS
- Address
- CARRETERA DE TERRASSA 121 RUB 08191 SP
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NOVOSYN VIOLET 1 (4) 90CM HR37S (M) | SYNTHETIC ABSORBABLE BRAIDED S | B. BRAUN SURGICAL, S.A. | GAM | C0068597 | C0068597 | 119462 | N | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH NOVOSYN VIOLET SUTURE. THE CLIENT REPORTED THAT DURING HANDLING THERE IS A SEPARATION OF THE NEEDLE FROM THE THREAD (NEEDLE DETACHMENT). SUTURES WERE USED FOR LAPAROSCOPIC SURGERY AND THE PROCEDURE WAS PROLONGED DUE TO THIS ISSUE. NO PATIENT INFORMATION IS AVAILABLE DUE TO PRIVACY PROTECTION.