MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-07 for WELCH ALLYN, INC. 901027 76720-TAX manufactured by Welch Allyn, Inc..
[178136413]
While a patient was being transferred from our emergency department to another of our facilities, a large blister was found on the patient's wrist. It was believed it could have happened while the patient was being seen in the emergency department. After an investigation, it was determined one possibility for the burn came from an otoscope used to transilluminate through the patient's palm. Our facility has since directed staff not to use an otoscope as a vein viewer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681173 |
| MDR Report Key | 9681173 |
| Date Received | 2020-02-07 |
| Date of Report | 2020-01-21 |
| Date of Event | 2020-01-10 |
| Report Date | 2020-01-21 |
| Date Reported to FDA | 2020-01-21 |
| Date Reported to Mfgr | 2020-02-07 |
| Date Added to Maude | 2020-02-07 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WELCH ALLYN, INC. |
| Generic Name | STAND, INSTRUMENT, AC-POWERED, OPHTHALMIC |
| Product Code | HMF |
| Date Received | 2020-02-07 |
| Model Number | 901027 |
| Catalog Number | 76720-TAX |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 12 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET ROAD SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-07 |