MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-26 for BRAUN THERMOSCAN PRO 6000 manufactured by Welch Allyn, Inc..
| Report Number | 8832129 |
| MDR Report Key | 8832129 |
| Date Received | 2019-07-26 |
| Date of Report | 2019-06-05 |
| Date of Event | 2019-05-05 |
| Report Date | 2019-06-05 |
| Date Reported to FDA | 2019-06-05 |
| Date Reported to Mfgr | 2019-07-26 |
| Date Added to Maude | 2019-07-26 |
| 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 | BRAUN THERMOSCAN PRO 6000 |
| Generic Name | THERMOMETER, ELECTRONIC, CLINICAL |
| Product Code | FLL |
| Date Received | 2019-07-26 |
| Returned To Mfg | 2019-05-16 |
| Model Number | PRO 6000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET ROAD WELCH ALLYN INC. CORPORATE HEADQUARTERS SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-07-26 |