MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-12 for FINGER RING CUTTER * manufactured by Global Instruments, Surgicare Supplies.
[19950814]
Reportedly this mfr has supplied us extremely poor quality ring cutters, that are rusted and have white powder like chemical on the instrument. They fail to do anything about it and we have defective ring cutter from them to show as proof.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040038 |
| MDR Report Key | 754197 |
| Date Received | 2006-08-12 |
| Date of Report | 2006-08-11 |
| Date of Event | 2006-07-05 |
| Date Added to Maude | 2006-08-28 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINGER RING CUTTER |
| Generic Name | RING CUTTER |
| Product Code | FNS |
| Date Received | 2006-08-12 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | 47-373 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 742010 |
| Manufacturer | GLOBAL INSTRUMENTS, SURGICARE SUPPLIES |
| Manufacturer Address | * TUCKER GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-12 |