MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-17 for SWANSON HUNTER manufactured by Wright Medical.
[45753818]
Non sterile spacer is packaged in similar fashion as the sterile implant. The warning that the spacers are not sterile is in very small print on the side of the box and can be easily missed. Both boxes are red and the same shape and size.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5062388 |
| MDR Report Key | 5669333 |
| Date Received | 2016-05-17 |
| Date of Report | 2016-05-17 |
| Date of Event | 2016-04-29 |
| Date Added to Maude | 2016-05-20 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SWANSON HUNTER |
| Generic Name | TENDON SPACERS |
| Product Code | KYI |
| Date Received | 2016-05-17 |
| Lot Number | 1574329 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WRIGHT MEDICAL |
| Manufacturer Address | MEMPHIS TN 38117 US 38117 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-17 |