MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2014-09-15 for MUH STEM SZ. 4.5 S MUH-600-S45S-WW manufactured by Ascension Orthopedics.
[4839612]
This is the first of three reports concerning the same surgery. It was reported that product id muh-600-s45s-ww was sent to the company rep and had expired prior to the surgery date. This was noticed prior to the surgery. The device was not in contact with the pt. A spare device was available and was used to complete the surgery. There was no delay in surgery reported.
Patient Sequence No: 1, Text Type: D, B5
[12406421]
The device involved in the reported incident has been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1651501-2014-00044 |
| MDR Report Key | 4115140 |
| Report Source | 07 |
| Date Received | 2014-09-15 |
| Date of Report | 2014-08-20 |
| Date of Event | 2014-08-20 |
| Date Mfgr Received | 2014-08-20 |
| Date Added to Maude | 2014-10-02 |
| 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 | MUH STEM SZ. 4.5 S |
| Generic Name | FIRSTCHOICE DRUJ |
| Product Code | KXE |
| Date Received | 2014-09-15 |
| Returned To Mfg | 2014-08-22 |
| Catalog Number | MUH-600-S45S-WW |
| Lot Number | 10-1698 |
| 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 | 2014-09-15 |