MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-12-10 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corp..
[4131223]
It was reported 'air bubble was admitted due to wrinkles stuck together on idrt sheet and first idrt opened could not be used. When first idrt ((b)(4)) was removed from the package and its tab was removed, surgeon admitted wrinkles already formed. After placing it in sterile saline basin, surgeon tried to smooth out wrinkles, but it did not work well'. The idrt was not used and there was no delay in surgery. Because the same size was not available, (b)(4) (idrt ts intl 1pk 4x10) was used to complete the surgery.
Patient Sequence No: 1, Text Type: D, B5
[11653876]
To date, the device involved in the reported incident has not been rec'd for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00060 |
| MDR Report Key | 3624383 |
| Report Source | 01,08 |
| Date Received | 2013-12-10 |
| Date of Report | 2013-12-10 |
| Date Mfgr Received | 2013-11-25 |
| Date Added to Maude | 2014-04-01 |
| 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 |
| 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 | 2013-12-10 |
| Catalog Number | 84051 |
| Lot Number | 105NA0261561 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-12-10 |