MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-10 for TR BAND TRB29-LRG manufactured by Terumo Medical Corporation.
[182762771]
Bladder malfunctioned. The one way valve did not hold the air in the bladder. When the inflator was removed the air escaped. Another device was used to obtain hemostasis.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9811294 |
| MDR Report Key | 9811294 |
| Date Received | 2020-03-10 |
| Date of Report | 2020-01-22 |
| Date of Event | 2020-01-15 |
| Report Date | 2020-01-22 |
| Date Reported to FDA | 2020-01-22 |
| Date Reported to Mfgr | 2020-03-10 |
| Date Added to Maude | 2020-03-10 |
| 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 |
| 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 | TR BAND |
| Generic Name | CLAMP, VASCULAR |
| Product Code | DXC |
| Date Received | 2020-03-10 |
| Model Number | TRB29-LRG |
| Catalog Number | TRB29-LRG |
| Lot Number | XG03 |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORPORATION |
| Manufacturer Address | 950 ELKTON BLVD. ELKTON MD 21921 US 21921 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-10 |