MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-29 for TRIMLINE 901043 manufactured by Welch Allyn, Inc..
[128758970]
Discovered approximately 12 disposable blood pressure cuffs that did not function. Tears were noted between the cuff and the rubber tubing.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8114865 |
| MDR Report Key | 8114865 |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-16 |
| Date of Event | 2018-11-13 |
| Report Date | 2018-11-16 |
| Date Reported to FDA | 2018-11-16 |
| Date Reported to Mfgr | 2018-11-29 |
| Date Added to Maude | 2018-11-29 |
| 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 | 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 | 3 |
| Brand Name | TRIMLINE |
| Generic Name | DISPOSABLE BP CUFF |
| Product Code | OEA |
| Date Received | 2018-11-29 |
| Catalog Number | 901043 |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN, INC. |
| Manufacturer Address | 4341 STATE STREET RD. SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-29 |