MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-09-06 for FLEXI PORT DISPOSIBLE B/P CUFF 901044 (01)00732094187335 manufactured by Welch Allyn, Inc..
| Report Number | MW5089632 |
| MDR Report Key | 8974963 |
| Date Received | 2019-09-06 |
| Date of Report | 2019-09-04 |
| Date of Event | 2019-09-03 |
| Date Added to Maude | 2019-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | RISK MANAGER |
| 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 | 0 |
| Brand Name | FLEXI PORT DISPOSIBLE B/P CUFF |
| Generic Name | BLOOD PRESSURE CUFF |
| Product Code | DXQ |
| Date Received | 2019-09-06 |
| Model Number | 901044 |
| Catalog Number | (01)00732094187335 |
| Lot Number | (10)18-101 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | SKANEATELES NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-09-06 |