MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-03-13 for IDRT, UNKNOWN XXX-IDRT manufactured by Integra Lifesciences Corporation.
[17929722]
A question was received by the distributor from the surgeon in which a burn patient was treated with integra's skin product last month. The patient's condition has not been well for a while and a medical examination finally found out that the patient got the acquired factor v deficiency. The surgeon said there was a report that bovine thrombin preparation has caused it and he wondered as to whether integra's skin product made of bovine collagen might be involved in the cause of the disease. Questions on past- adverse events reported in use of the integra's skin and if the use of integra's skin product have ever caused acquired factor v deficiency were posed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[18049876]
There is no bovine thrombin in the integra dermal regeneration template product. There has never been reported a case of acquired factor v deficiency with integra dermal regeneration template or any other collagen product that integra manufactures. 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 | 1121308-2013-00002 |
| MDR Report Key | 3008360 |
| Report Source | 01,08 |
| Date Received | 2013-03-13 |
| Date of Report | 2013-03-13 |
| Date Mfgr Received | 2013-02-20 |
| Date Added to Maude | 2013-03-19 |
| 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 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 |
| Brand Name | IDRT, UNKNOWN |
| Generic Name | INTEGRA |
| Product Code | MGR |
| Date Received | 2013-03-13 |
| Catalog Number | XXX-IDRT |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-13 |