MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-19 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corporation.
[62797540]
It was reported hypertrophic scars formed on the patient postoperatively. ? The area where idrt has been used is well recognizable. A sample of this area will be examined by tissue engineering and the clinic will be informed of the results. The presumption of the clinic, however, is that the hypertrophic scars lie outside the site.? It was reported the product was in contact with the patient. It was reported patient injury is? Unknown.? It was reported the material was in the patient about 9 months. Revision was necessary because of scars.
Patient Sequence No: 1, Text Type: D, B5
[64444951]
Additional information received on january 10, 2017: female patient with an injury caused by an acid attack at the neck, left side. The procedure was (b)(6). The area where idrt has been used is very good recognizable. The surgeon confirmed that the hypertrophic scar is an area which was not treated with idrt.
Patient Sequence No: 1, Text Type: N, H10
[65711519]
Integra has completed their internal investigation on january 20, 2017. The investigation included: methods: review of device history records review of complaints history results: the failure is unconfirmed as there was no product returned for this complaint. The product was implanted in the patient during surgery, 9 months before this complaint was initiated, and cannot be returned for failure analysis. Therefore, failure analysis could not be performed. Dhr review; no product lot number was provided with this complaint; therefore, dhr review cannot be performed complaints history; no other complaint except the current one was found. (b)(4). Conclusion: undetermined, however, the occurrence of hypertrophic scar in this patient is unrelated to the idrt product supplied by ils. This was confirmed by the doctor? S statement from the reporting facility which clearly indicated that the hypertrophic scar tissue observed in this patient was in an area which was not treated with idrt, and that the area treated with idrt was very well recognizable.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2016-00021 |
| MDR Report Key | 6187348 |
| Date Received | 2016-12-19 |
| Date of Report | 2016-12-07 |
| Date of Event | 2016-12-07 |
| Date Mfgr Received | 2017-01-20 |
| Date Added to Maude | 2016-12-19 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER MARIA LEONARD |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION |
| 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-TS (INTL) SINGLE 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2016-12-19 |
| Catalog Number | 84051 |
| 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 CORPORATION |
| Manufacturer Address | 105 MORGAN LANE 105 MORGAN LANE PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-12-19 |