MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2013-12-09 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..
[4135278]
This is the first report of three involving the idrt bilayer from the same facility involving the same surgeon, issue and product. It was reported: "the first case was an elderly pt who required two pieces of 5cms x 5cms idrt bilayer. One of the pieces was badly kinked, which created a ridge running roughly through the centre of the template. The surgeon tried in vain to straighten the piece out, in order to achieve the required contact between idrt and wound. Owing to the nature of the silicone, it would not straighten, but he was forced to use it, as it was the only one available. The second piece, of the same lot number, was fine. Surgery was delayed by 20 minutes. There was not pt injury alleged".
Patient Sequence No: 1, Text Type: D, B5
[11513292]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00057 |
| MDR Report Key | 3624313 |
| Report Source | 01,05,07 |
| Date Received | 2013-12-09 |
| Date of Report | 2013-12-09 |
| Date Mfgr Received | 2013-11-13 |
| Date Added to Maude | 2014-04-01 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | CAREN FINKELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MDD |
| Date Received | 2013-12-09 |
| Catalog Number | XXX-IDRT |
| Lot Number | 105A00269823 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-09 |