MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-16 for WELCH ALLYN SOFT-11 manufactured by Hygia Health Services, Inc..
[145256582]
Blood pressure cuff exploded while inflating on patients arm. Total of 3 occurrences on this date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8615483 |
| MDR Report Key | 8615483 |
| Date Received | 2019-05-16 |
| Date of Report | 2019-05-02 |
| Date of Event | 2019-04-29 |
| Report Date | 2019-05-02 |
| Date Reported to FDA | 2019-05-02 |
| Date Reported to Mfgr | 2019-05-16 |
| Date Added to Maude | 2019-05-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 |
| Generic Name | REPROCESSED BLOOD PRESSURE CUFF |
| Product Code | NPP |
| Date Received | 2019-05-16 |
| Model Number | SOFT-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HYGIA HEALTH SERVICES, INC. |
| Manufacturer Address | 432-434 INDUSTRIAL LN. BIRMINGHAM AL 35211 US 35211 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-16 |