MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,05,07 report with the FDA on 2014-07-24 for IDRT SINGLE LAYER (INTL) 2X2 5 PACK 62025 manufactured by Integra Lifesciences Corp..
[4951687]
It was reported during a study conducted in (b)(6), titled: "clinical outcome of defect reconstruction using idrt single layer: results from a prospective multicentric trial;' implantation of the idrt sl in one step on (b)(6) 2013. On (b)(6) 2013 the graft did not succeed (loss of the graft from 20 to 100%). A new graft was performed on (b)(6) 2013. Add'l info was received on 07/04/2014. The implantation was in the foot, the graft did not succeed (loss of the graft from 20 to 100%) means partial split thickness skin graft (stsg) loss.
Patient Sequence No: 1, Text Type: D, B5
[11953104]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00024 |
| MDR Report Key | 4004708 |
| Report Source | 01,02,05,07 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-02 |
| Date of Event | 2013-09-28 |
| Date Mfgr Received | 2014-07-02 |
| Date Added to Maude | 2014-08-14 |
| 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 | CAREN FINFELSTEIN |
| Manufacturer Street | 315 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IDRT SINGLE LAYER (INTL) 2X2 5 PACK |
| Generic Name | IDRT |
| Product Code | MGR |
| Date Received | 2014-07-24 |
| Catalog Number | 62025 |
| Lot Number | 105B00254166 |
| Device Expiration Date | 2014-07-31 |
| 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. Required No Informationntervention | 2014-07-24 |