MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-11-04 for COMFORT BAND * manufactured by Tz Medical, Inc.
[15192156]
The doctor did a radial case and post procedure asked for a comfort band. The nurse gave him the comfort band from lab 2 stock. (b)(4). He removed the sheath and applied the band to the patient's wrist. He stated he needed a new band due to this one bending in the middle portion that goes over the arterial site. The nurse retrieved another band. The doctor said he prefers this one. (b)(4). The two bands look the same except for a crease in the middle of the band that goes over arterial site. He stated that the first one does not hold the site well enough for hemostasis. The second band was applied. The doctor doesn't care for the new design. The old design is no longer available for purchase. We are investigating other option to offer the doctor. The patient was without bleeding or discomfort in right wrist. No harm done to patient. The doctor didn't care for the first band due to it bending in the middle portion that goes over the arterial site and does not hold as good, so they change to (b)(4) which does a better job.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2327430 |
| MDR Report Key | 2327430 |
| Date Received | 2011-11-04 |
| Date of Report | 2011-11-04 |
| Date of Event | 2011-10-01 |
| Report Date | 2011-11-04 |
| Date Reported to FDA | 2011-11-04 |
| Date Added to Maude | 2011-11-08 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMFORT BAND |
| Generic Name | COMFORT BAND |
| Product Code | MHW |
| Date Received | 2011-11-04 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | CB-A0201B |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TZ MEDICAL, INC |
| Manufacturer Address | 7272 SW DURHAM ROAD, SUITE 8OO PORTLAND OR 97224 US 97224 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-04 |