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 2013-10-31 for IDRT SINGLE LAYER (INTL) 4X5 5 PACK 64055 manufactured by Integra Lifesciences Corp..
[3941661]
It was reported during a post approval study conducted in the (b)(6) titled: clinical outcome of defected reconstruction using idrt single layer. Results from a prospective multicenter trial; the patient had surgery on 08-august-2013 with integra dermal regeneration template (idrt) in one step surgery for a scar revision on the left arm. On 22 aug-2013 the patient experienced a 20% graft loss noted in comparison to his previous visit and "malodor" (wound swabs were taken for analysis). The patient started treatment with on oral antibiotic: flucloxacillin by the "gp". The culture was positive for staphylococcus aureaus which was grown from wounds. Daily bactroban/jelonet dressings were commenced from 29-august-2013. It was advised (the patient) continue this dressing change plan for another 14 days.
Patient Sequence No: 1, Text Type: D, B5
[11414644]
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 | 1121308-2013-00055 |
| MDR Report Key | 3466566 |
| Report Source | 01,02,05,07 |
| Date Received | 2013-10-31 |
| Date of Report | 2013-10-31 |
| Date Mfgr Received | 2013-10-14 |
| Date Added to Maude | 2013-11-14 |
| 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 DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362341 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORP. |
| Manufacturer Street | 105 MORGAN LANE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 08536 |
| 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 | 2013-10-31 |
| Catalog Number | 64055 |
| Lot Number | 105B00259670 |
| 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 | 2013-10-31 |