MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-11-05 for INSTY SPLINT manufactured by Apothecary Procucts, Inc..
[713045]
I bought a 2-sided finger splint. It was manufactured in another country and sold through apothecary products. It came in a box with two splints. The splint with one hook and loop band didn't work too bad. But i have been using the one with 2 hook and loop bands and the bands will not pull tight. I am walking around with a splint with bands hanging down not fastened because they won't stay fastened. They advertise this to use on a wound after you have the bleeding stopped. You can not get enough pressure with this due to the band situation to help stop a wound from bleeding like they claim.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5004337 |
| MDR Report Key | 939379 |
| Date Received | 2007-11-05 |
| Date of Report | 2007-11-05 |
| Date of Event | 2007-11-05 |
| Date Added to Maude | 2007-11-14 |
| 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 | 0 |
| Reporter Occupation | PATIENT |
| 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 | INSTY SPLINT |
| Generic Name | FINGER SPLINT |
| Product Code | FYH |
| Date Received | 2007-11-05 |
| ID Number | STOCK # 97451 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 915040 |
| Manufacturer | APOTHECARY PROCUCTS, INC. |
| Manufacturer Address | MINNEAPOLIS MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-11-05 |