MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,08 report with the FDA on 2014-03-25 for IDRT-TS 8X10 SINGLE DOMESTIC 38101 manufactured by Integra Lifesciences Corp.
[4451033]
It was reported: 'the sterile packaging appears to have moisture damage and excess moisture inside that looks like its packaging may have leaked. It was not opened and was not used for surgery. '
Patient Sequence No: 1, Text Type: D, B5
[11788302]
To date the device involved in the reported incident has not been received for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00011 |
| MDR Report Key | 3815918 |
| Report Source | 05,06,07,08 |
| Date Received | 2014-03-25 |
| Date of Report | 2014-03-07 |
| Date Mfgr Received | 2014-03-07 |
| Date Added to Maude | 2014-06-13 |
| 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 SINGLE DOMESTIC |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2014-03-25 |
| Catalog Number | 38101 |
| Lot Number | 105A002859550 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2014-03-25 |