MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2014-08-06 for MCP DISPOSABLE PACK FOR LINVATEC/HALL MCP-DIS-HAL manufactured by Ascension Orthopedics.
[18289917]
It was reported that debris was found inside the sterile pouch next to the mcp implant. Additional information was received from the product manager. "the mcp implant was implanted then the debris was noted. If it had been noticed when they opened it (the package), they would have opened a new once. " a spare device was available. No adverse consequence or injury to the patient was reported. The reporter noted the facility indicated they did not want to be contacted for further information.
Patient Sequence No: 1, Text Type: D, B5
[18533956]
The device packaging involved in the reported incident has been received for evaluation. An investigation has been initiated on the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00037 |
| MDR Report Key | 4222868 |
| Report Source | 06,07 |
| Date Received | 2014-08-06 |
| Date of Report | 2014-07-18 |
| Date of Event | 2014-07-18 |
| Date Mfgr Received | 2014-07-18 |
| Date Added to Maude | 2014-11-06 |
| 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 085363832 |
| Manufacturer Country | US |
| Manufacturer Postal | 085363832 |
| Manufacturer Phone | 6099362341 |
| Manufacturer G1 | ASCENSION ORTHOPEDICS, INC. |
| Manufacturer Street | 8700 CAMERON RD., STE. 100 |
| Manufacturer City | AUSTIN TX 78754383 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78754 3832 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MCP DISPOSABLE PACK FOR LINVATEC/HALL |
| Generic Name | MCP DISPOSABLE PACKS |
| Product Code | KYI |
| Date Received | 2014-08-06 |
| Returned To Mfg | 2014-07-24 |
| Catalog Number | MCP-DIS-HAL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASCENSION ORTHOPEDICS |
| Manufacturer Address | AUSTIN TX 78754 US 78754 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-06 |