MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2014-08-21 for IDRT-TS (INTL) SINGLE 8X10 88101 manufactured by Integra Lifesciences Corp..
[16185411]
It was reported a (b)(6) old child, about 1 year ago, received removal of a nevus and had idrt applied. After the autograft was received, the pt experienced bulging. When dissected that bulging area, each lump was filled with scurf-like-substance. Underneath of the lumps was epithelialized. Reportedly, neodermis formation was not admitted well. The pt is now undergoing treatment after second nevus removal with idrt applied. Skin where once dissected is treated conservatively, but still something very similar to shredded dry skin is coming off. Additional info was received by integra (b)(4) 2014 from the user facility to the distributor: in response to additional info requested. We confirmed that second idrt implanted is nothing to do with the reported complaint. It was implanted because the size of nevus was too large to cover it with first idrt. The first idrt was implanted on the back and second idrt implanted around the neck to the upper shoulder. What does "scurf-like substance" mean? Sorry for the confusion due to my choice of word. Reportedly, white substance looks like keratinocyte. Are photos available? No, but our sales rep got to see them. It's very similar to the case we reported previously. (see mfg report number # 1121308-2014-00023. When was the first application of idrt? On (b)(6) 2013. How long (timeframe) after the first idrt graft was implanted did the pt experience the "bulging"? An autograft was applied on (b)(6) 2013 in a week, poor take of autograft was admitted and partially it fell off. Within another week, the autograft sort of came up, not taken very well anyway. Was any treatment provided? Please provide treatment dates if applicable. Ointment application only. Reportedly, neodermis formation was not admitted well. Specifically, the neodermis looked bumpy. The doctor still does not have a clue what is attributable to such phenomenon.
Patient Sequence No: 1, Text Type: D, B5
[16443434]
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 | 1121308-2014-00044 |
| MDR Report Key | 4095297 |
| Report Source | 01,06,08 |
| Date Received | 2014-08-21 |
| Date of Report | 2014-08-04 |
| Date of Event | 2013-08-20 |
| Date Mfgr Received | 2014-08-04 |
| Date Added to Maude | 2014-09-26 |
| 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-TS (INTL) SINGLE 8X10 |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2014-08-21 |
| Catalog Number | 88101 |
| Lot Number | 105NA0261882 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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. Other | 2014-08-21 |