MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2008-02-28 for WELCH ALLYN RECHARGEABLE 3.5 V BATTERY 77200 manufactured by Welch Allyn, Inc.
[18604779]
Welch allyn rechargeable battery in ophthalmoscope found to be scorched heavily with melting of battery covering. Battery date was august 10. New battery, also dated august 10 placed into scope. Scope was laid on counter for physician to use, never put back into charger. Within moments, scope began smoking, handle extremely hot to touch. Battery was able to be removed. Showed scorching and melting of battery covering. Paper underneath where removed battery was laid also scorched. This was second such incident. Dates of use: 2008.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5005733 |
| MDR Report Key | 1005277 |
| Date Received | 2008-02-28 |
| Date of Report | 2008-02-28 |
| Date of Event | 2008-02-27 |
| Date Added to Maude | 2008-03-13 |
| 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 | WELCH ALLYN RECHARGEABLE 3.5 V BATTERY |
| Generic Name | NONE |
| Product Code | FCO |
| Date Received | 2008-02-28 |
| Returned To Mfg | 2008-02-28 |
| Model Number | 77200 |
| Lot Number | 0810 |
| Device Expiration Date | 2010-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 977359 |
| Manufacturer | WELCH ALLYN, INC |
| Manufacturer Address | SKANEATELES FALLS NY 13153 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2008-02-28 |