D
Patient 1
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT DEVELOPED A REACTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
MAUDE MDR 2838173
- MDR report key
- 2838173
- Report number
- 2210968-2012-07432
- Event key
- 0
- Event type
- 3
- Date received
- 2012-11-19
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MR. DANIEL LAMONT
- Address
- ROUTE 22 WEST PO BOX 151 SOMERVILLE NJ 08876 US
- Phone
- 908-908-9082
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ETHIBOND EXTRA & EXCEL POLYESTER SUTURE | SUTURE, NON-ABSORBABLE | ETHICON, INC. | GAS | NA | NI | NI | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-11-19 | 0 | 1. O |
Event Narratives#
N
Patient 1
(B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.