MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-01-08 for BOSTON SICENTIFIC 840802 manufactured by Boston Scientific.
[20621283]
Distributor boston scientific legal manufacturer is listed as innova quartz. Package #1 laser fiber noted in trf 101018f broke in physician's hand and resulted in a burn to hand. New fiber obtained from cad unit and fiber with second device, fibers on device broke as it was being pulled from the package. Labels of both devices included. Physician burn on tip of left index finger. Will seek treatment after causes are completed. Size is described as pencil eraser size.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5009559 |
| MDR Report Key | 1282224 |
| Date Received | 2009-01-08 |
| Date of Report | 2009-01-07 |
| Date of Event | 2009-01-07 |
| Date Added to Maude | 2009-01-21 |
| 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 | RISK MANAGER |
| 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 | BOSTON SICENTIFIC |
| Generic Name | HOLMIUM LASER FIBER |
| Product Code | LNK |
| Date Received | 2009-01-08 |
| Catalog Number | 840802 |
| Lot Number | TRF1018F |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BOSTON SCIENTIFIC |
| Manufacturer Address | ONE BOSTON SCIENTIFIC PLACE NATICK MA 01760153 US 01760 1537 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2009-01-08 |