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 2014-10-08 for IDRT SINGLE LAYER (INTL) 4X5 5 PACK 64055 manufactured by Integra Lifesciences Corp..
[5027556]
This event is being reported as part of a study conducted in (b)(6) titled " (b)(6) " it was reported "the patient was operated and implanted with idrt sl in 1 stage on (b)(6) 2014. At the 6 months visit (on (b)(6) 2014), the study coordinator reports that patient presented skin pigmentation very dark brown, in comparison to other scars and normal skin. Patient received an autograft taken from the thigh. Patient has not had any sun exposure. No treatment for the moment but patient was referred for laser.
Patient Sequence No: 1, Text Type: D, B5
[12363347]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00066 |
| MDR Report Key | 4168952 |
| Report Source | 01,02,05,07 |
| Date Received | 2014-10-08 |
| Date of Report | 2014-09-11 |
| Date of Event | 2014-08-18 |
| Date Mfgr Received | 2014-09-11 |
| Date Added to Maude | 2014-10-16 |
| 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 FINKLESTEIN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| 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) 4X5 5 PACK |
| Generic Name | IDRT |
| Product Code | MDD |
| Date Received | 2014-10-08 |
| Catalog Number | 64055 |
| Lot Number | 105B00259670 |
| Device Expiration Date | 2014-09-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2014-10-08 |