MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2011-08-19 for SUBTALAR MBA IMPLANT 14MM 050114 manufactured by Integra, Cincinnati.
[2300906]
The reporter stated that the user facility implanted two expired devices on (b)(6) 2011. The products expired on (b)(6) 2011. The patient was anesthetized and in the operating room. He needed size 14mm implants. Integra no longer market this size implant. The user facility elected to sterile process the devices using joint commission guidelines. The products were purchased by the hospital on 11/24/2006, therefore, inventory has been in the possession of the hospital for almost 5 years. The integra distributor was not present at the surgery.
Patient Sequence No: 1, Text Type: D, B5
[9457150]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2011-00120 |
| MDR Report Key | 2249625 |
| Report Source | 05,07 |
| Date Received | 2011-08-19 |
| Date of Report | 2011-08-19 |
| Date of Event | 2011-07-01 |
| Date Mfgr Received | 2011-07-29 |
| Date Added to Maude | 2012-03-30 |
| 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 | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DR. |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBTALAR MBA IMPLANT 14MM |
| Generic Name | NA |
| Product Code | MJW |
| Date Received | 2011-08-19 |
| Catalog Number | 050114 |
| Lot Number | 10138-14-10321 |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA, CINCINNATI |
| Manufacturer Address | CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-19 |