MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for GILL 91 SPATULA AND PACKER GILL91 manufactured by Gill Podiatry Supply Co..
[184277111]
Doctor was doing a toenail removal and a piece of one of the tools broke off in the patient's skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859819 |
| MDR Report Key | 9859819 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-02-19 |
| Date of Event | 2020-02-18 |
| Report Date | 2020-02-24 |
| Date Reported to FDA | 2020-02-24 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Brand Name | GILL 91 SPATULA AND PACKER |
| Generic Name | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| Product Code | MDM |
| Date Received | 2020-03-20 |
| Model Number | GILL91 |
| Catalog Number | GILL91 |
| Lot Number | 97-0542 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GILL PODIATRY SUPPLY CO. |
| Manufacturer Address | 22400 ASCOR COURT STRONGSVILLE OH 44149 US 44149 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |