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 NONE manufactured by Integra Lifesciences Corp..
[3557907]
This is the third of three reports regarding idrt (product id not provided). It was reported that the customer is doing a retrospective study of idrt and reported 3 cases of allergy with idrt since 1995 in his hospital. The pts were three degree burned, they had several grafts of idrt, and had delay in cicatrization with some reactions like eczema in the graft area. Product will not be returned. Additional info has been requested; however, when the sales rep met with the doctor, he only managed to see the pt file on one pt and not for the pt in this report.
Patient Sequence No: 1, Text Type: D, B5
[10858594]
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 | 1121308-2013-00023 |
| MDR Report Key | 3181463 |
| Report Source | 01 |
| Date Received | 2013-06-17 |
| Date of Report | 2013-06-17 |
| Date Mfgr Received | 2013-05-29 |
| 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 | 0 |
| 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 |
| Generic Name | NONE |
| Product Code | MGR |
| Date Received | 2013-06-17 |
| 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 |