MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-25 for ST. JUDE 905 manufactured by St. Jude Medical.
[4637002]
Scrub nurse handed 27mm st jude sizer to surgeon: handle intact, scrub nurse received 27mm st jude sizer back from surgeon in two pieces with approx 1cm of plastic material missing from sizer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5037472 |
| MDR Report Key | 3966362 |
| Date Received | 2014-07-25 |
| Date of Report | 2014-07-16 |
| Date of Event | 2014-07-15 |
| Date Added to Maude | 2014-07-31 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ST. JUDE |
| Generic Name | VALVE SIZER |
| Product Code | DTI |
| Date Received | 2014-07-25 |
| Model Number | 905 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL |
| Manufacturer Address | 6300 BEE AVE RD STE 100 BUILDING TWO AUSTIN TX 78746583 US 78746 5833 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-25 |