MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-28 for SKLAR STERILE TOE NAIL REMOVAL TRAY CS/10 94-5341 manufactured by Unk.
[140595152]
Sklar sterile toenail removal toenail removal tray cs/10 reorder number (b)(4) is not labeled for single use. Manufacturer has been contacted and instruments have been verified as single use only and our clinic has had issues with re-sterilization which can potentially lead to an adverse event. Sklar corporation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5085375 |
| MDR Report Key | 8465718 |
| Date Received | 2019-03-28 |
| Date of Report | 2019-03-26 |
| Date of Event | 2019-03-26 |
| Date Added to Maude | 2019-03-29 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | SKLAR STERILE TOE NAIL REMOVAL TRAY CS/10 |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2019-03-28 |
| Catalog Number | 94-5341 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-28 |