MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-06-13 for NONE manufactured by Integra Lifesciences Corp..
[3516638]
This is the first of three reports regarding idrt (product id not provided). It was reported that the doctor is doing a retrospective study of idrt and reported 3 cases of allergy with idrt since 1995 in his hospital. The patients were third 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 information has been requested and the following information was obtained on (b)(6) 2013: the doctor is trying to understand the side effects which are probably not linked to idrt. The allergist indicated that if he test idrt, he will also test the other product used on the patient during treatment. The doctor and allergist permitted the sales representative to see the file of one of the patient concerned by the study. The involved patient in this report is a young women who has been splashed with benzine, inflamed, and was burned on 80% of her body. The idrt was used as treatment on all the burn area. The pictures showed a good evolution on the trunk (idrt in place during 40 days), the arm and the rest of the wound. Only an infection appears at the foot. This part has been treated with idrt but it appears in this area: inflammatory, granular, and cheloid aspect. The patient was treated during a long time for this issue. The sales representative did not see the file of the 2 other patients included in the study.
Patient Sequence No: 1, Text Type: D, B5
[10850563]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00025 |
| MDR Report Key | 3179576 |
| Report Source | 01 |
| Date Received | 2013-06-13 |
| Date of Report | 2013-06-13 |
| Date Mfgr Received | 2013-05-29 |
| Date Added to Maude | 2013-06-21 |
| 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 DRIVE |
| 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 | MDD |
| Date Received | 2013-06-13 |
| 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 | 2013-06-13 |