MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-06-17 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corp..
[3558420]
This is the second of three reports regarding idrt (same reaction, different pts, and different surgeons). It was reported that the event has been happening from time to time without any evident reason. During the regeneration process, the issue was also generating a kind of granulous skin on some areas (not the granulation tissue), a kind of acne. The customer does not think it is an allergy because on one pt, a large surface of the body was covered by the product and only a small surface under one sheet had this skin disorder. No pt injured reported, just a reaction that was not expected and without explanation. No further info available.
Patient Sequence No: 1, Text Type: D, B5
[10859281]
The device involved in the reported incident is not expected to be received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00027 |
| MDR Report Key | 3181534 |
| Report Source | 01 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-06-17 |
| Date Mfgr Received | 2013-06-07 |
| Date Added to Maude | 2013-06-24 |
| 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 | ROWENA SALVADOR |
| Manufacturer Street | 315 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MGR |
| Date Received | 2013-06-17 |
| Catalog Number | XXX-IDRT |
| 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 | 1. Other | 2013-06-17 |