MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2014-11-17 for IDRT-TS (INTL) SINGLE 4X5 84051 manufactured by Integra Lifesciences Corp..
[5082547]
It was reported that during a surgical procedure a small hole was found in the inner package. There was evident liquid leakage from the hole which caused suspicion of compromised sterility. Additional info received indicates the pt was under anesthesia when this even occurred. It was reported there were no consequences for the pt, just a little delay. The procedure was finished by replacing with a new package, available at the moment of surgery.
Patient Sequence No: 1, Text Type: D, B5
[12595530]
To date, the device involved in the reported incident has not been received for eval. An investigation has been initiated based upon the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1121308-2014-00070 |
| MDR Report Key | 4289720 |
| Report Source | 01,08 |
| Date Received | 2014-11-17 |
| Date of Report | 2014-10-22 |
| Date of Event | 2014-10-01 |
| Date Mfgr Received | 2014-10-22 |
| Date Added to Maude | 2014-12-04 |
| 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 | MARIA LEONARD |
| Manufacturer Street | 311 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 4X5 |
| Generic Name | IDRT-TS |
| Product Code | MDD |
| Date Received | 2014-11-17 |
| Catalog Number | 84051 |
| Lot Number | 105NC0265989 |
| 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 CORP. |
| Manufacturer Address | PLAINSBORO NJ 08536 US 08536 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-11-17 |