MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07,08 report with the FDA on 2013-10-23 for IDRT-TS 8X10 5 PACK DOMESTIC 38105 manufactured by Integra Lifesciences Corp..
[21661462]
It was reported that one of five pieces of integra dermal regeneration template (idrt) in the dispenser box leaked the buffer solution from the foil pouch and was seen in the tyvek pouch. Some of the fluid leaked from the tyvek pouch onto the packaging. The product was not opened or used.
Patient Sequence No: 1, Text Type: D, B5
[22007134]
The device involved in the reported incident has been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2013-00054 |
| MDR Report Key | 3539108 |
| Report Source | 06,07,08 |
| Date Received | 2013-10-23 |
| Date of Report | 2013-10-23 |
| Date Mfgr Received | 2013-10-04 |
| Date Added to Maude | 2014-01-27 |
| 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 8X10 5 PACK DOMESTIC |
| Generic Name | IDRT-TS |
| Product Code | MGR |
| Date Received | 2013-10-23 |
| Catalog Number | 38105 |
| Lot Number | 105B00279717 |
| Device Expiration Date | 2015-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-10-23 |