MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2004-08-05 for NICKLE CADMIUM BATTERY FOR LIGHT HANDLE 72200 manufactured by Welch Allyn.
[382538]
A new nicad rechargeable battery was being placed into an otoscope light handle when the battery reportedly caught on fire. The user was not reported injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1316463-2004-00008 |
| MDR Report Key | 616588 |
| Report Source | 05 |
| Date Received | 2004-08-05 |
| Date of Event | 2004-07-02 |
| Date Mfgr Received | 2004-07-02 |
| Date Added to Maude | 2005-06-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 0 |
| Manufacturer Contact | MICHAEL LAUGHRAN |
| Manufacturer Street | P.O. BOX 220 |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 7724854533 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NICKLE CADMIUM BATTERY FOR LIGHT HANDLE |
| Generic Name | OTOSCOPES |
| Product Code | ERA |
| Date Received | 2004-08-05 |
| Model Number | 72200 |
| Catalog Number | 72200 |
| Lot Number | NOVEMBER 2006 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 606324 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | * SKANEATELES NY * US |
| Baseline Brand Name | NICKLE CADMIUM BATTERY FOR LIGHT HANDLE |
| Baseline Generic Name | OTOSCOPES |
| Baseline Model No | 72200 |
| Baseline Catalog No | 72200 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2004-08-05 |