MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-08-19 for WELCH ALLYN TRANSFORMER OTOSCOPE 76710 manufactured by Welch Allyn, Inc..
[15125897]
Patient was resting in the bed. Pillow was hot. Face was hot. Mom lifted pillow and found otoscope under pillow. She picked it up and immediately dropped it as it was hot. Findings: mom was seen in ed. First degree burn to finger tips. No blistering. Painful to palpation. Neurovascularly was intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4026914 |
| MDR Report Key | 4026914 |
| Date Received | 2014-08-19 |
| Date of Report | 2014-08-19 |
| Date of Event | 2014-08-09 |
| Report Date | 2014-08-19 |
| Date Reported to FDA | 2014-08-19 |
| Date Reported to Mfgr | 2014-08-21 |
| Date Added to Maude | 2014-08-21 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | WELCH ALLYN TRANSFORMER OTOSCOPE |
| Generic Name | OTOSCOPE |
| Product Code | ERA |
| Date Received | 2014-08-19 |
| Model Number | 76710 |
| Catalog Number | 76710 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 3 YR |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET ROAD SKANEATELES FALLS NY 13151 US 13151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-08-19 |