MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-11-14 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corp..
[22262890]
After 15 to 20 days of integra dermal regeneration template (drt) implantation on a (b)(6) male patient burned after a gas bottle explosion, the patient died. On autopsy report, it stated that the patient died from burns (over 30% of his body was burned) which also caused sepsis. There was confirmation that everything was ok with the placed idrt. Additional information was received on (b)(6) 2014 with the following: date of death was on (b)(6) 2014. The idrt was implanted on (b)(6) 2014. The patient had 30% burns over his body. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[22279722]
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 | 1121308-2014-00071 |
| MDR Report Key | 4257383 |
| Report Source | 01,08 |
| Date Received | 2014-11-14 |
| Date of Report | 2014-10-19 |
| Date of Event | 2014-08-12 |
| Date Mfgr Received | 2014-10-20 |
| Date Added to Maude | 2014-11-19 |
| 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 BURUAN |
| 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-TS (INTL) SINGLE 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2014-11-14 |
| Catalog Number | 84051 |
| Lot Number | 105NB0299336 |
| Device Expiration Date | 2016-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2014-11-14 |