D
Patient 1
IT WAS REPORTED THAT 'DURING THE SURGERY WHEN THE PACKAGE WAS OPENED, CREASES WERE ADMITTED IN THE FIRST IDRT. ANOTHER IDRT WAS OPENED AND USED TO COMPLETE THE SURGERY.'
MAUDE MDR 3818580
- MDR report key
- 3818580
- Report number
- 1121308-2014-00013
- Event key
- 0
- Event type
- 3
- Date received
- 2014-04-02
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- CAREN FINKELSTEIN
- Address
- 315 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
- Phone
- 609-609-6099
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | IDRT-TS (INTL) SINGLE 2X2 | IDRT-TS | INTEGRA LIFESCIENCES CORP. | MGR | 82021 | 105NA0277860 | * | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-04-02 | 0 |
Event Narratives#
N
Patient 1
TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION.