MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-25 for GEM 884 C CARBIDE DISK #244 manufactured by Mw Mooney & Co. Inc..
[320492]
Nurse was removing rings from patient utilizing gem ring cutting system including finger guard. During cutting of second ring, nurse noted small amount of blood under finger guard. Finger guard then noted to be cut through. Abrasion/small laceration noted palm surface of left ring finger. Failure of shielding.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 526937 |
| MDR Report Key | 526937 |
| Date Received | 2004-05-25 |
| Date of Report | 2004-05-21 |
| Date of Event | 2004-05-21 |
| Date Facility Aware | 2004-05-21 |
| Report Date | 2004-05-21 |
| Date Reported to FDA | 2004-05-24 |
| Date Reported to Mfgr | 2004-05-24 |
| Date Added to Maude | 2004-05-28 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GEM |
| Generic Name | BATTERY OPERATED RING CUTTER |
| Product Code | FNS |
| Date Received | 2004-05-25 |
| Model Number | 884 C CARBIDE DISK |
| Catalog Number | #244 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 516101 |
| Manufacturer | MW MOONEY & CO. INC. |
| Manufacturer Address | 415 WILLIAMSON WAY #1 ASHLAND OR 97520 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-05-25 |