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..
[16991805]
It was reported during a study conducted in (b)(6), titled: (b)(4), implantation of the idrt sl in one step to foot of pt on (b)(6) 2013. On (b)(6) 2013, the graft partially failed (0-20%). Change of dressing and monitoring of the pt was performed. The event was resolved (closure of the wound) on (b)(6) 2014.
Patient Sequence No: 1, Text Type: D, B5
[17004950]
Idrt-sl is not approved for sale in the united states and this study investigated a technique not included in the united states. 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 | 1121308-2014-00026 |
| MDR Report Key | 4004709 |
| Report Source | 01,02,05,07 |
| Date Received | 2014-07-24 |
| Date of Report | 2014-07-02 |
| Date of Event | 2013-12-17 |
| 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 FINKELSTEIN |
| 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 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. Required No Informationntervention | 2014-07-24 |