MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-07-13 for COMPRESSION DEVICE manufactured by Terumo Medical Corp..
[2842764]
Stent to rca via radial approach - tr band applied prior to transfer to recovery room. Act 165 with additional 4000 units of heparin given. Hematoma discovered upon arrival. Tr band removed, hemostasis obtained using manual compression. New tr applied. Once manual compression was applied, skin tear occurred with exposure of fatty tissue. Skin required sutures to repair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5026194 |
| MDR Report Key | 2660968 |
| Date Received | 2012-07-13 |
| Date of Report | 2012-07-13 |
| Date of Event | 2012-07-09 |
| Date Added to Maude | 2012-07-20 |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPRESSION DEVICE |
| Generic Name | TR BAND |
| Product Code | MHW |
| Date Received | 2012-07-13 |
| Lot Number | 0000000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO MEDICAL CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-07-13 |