MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-05-03 for RANFAC BREAST MARKING/BRACKENING 5B37.5 manufactured by Ranfac. Corp.
[2026002]
Wire fragment broke off during procedure. Surgeon found fragment and used a second unit to complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5020496 |
| MDR Report Key | 2081800 |
| Date Received | 2011-05-03 |
| Date of Report | 2011-05-04 |
| Date of Event | 2011-04-29 |
| Date Added to Maude | 2011-05-12 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RANFAC BREAST MARKING/BRACKENING |
| Generic Name | NONE |
| Product Code | MIJ |
| Date Received | 2011-05-03 |
| Catalog Number | 5B37.5 |
| Lot Number | 21032615 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RANFAC. CORP |
| Manufacturer Address | 30 DOHERTY ST AVON MA 02322 US 02322 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-05-03 |