MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-07-07 for ALPHA LINER manufactured by Ohio Willow Wood.
[2104627]
I am an amputee that was fitted with 2 faulty liners produced by (b)(4). These liners are distributed by (b)(4). The liners are thin in the front and developed a small hole which caused an ulcer in my stump. I was treated by the burn wound center at (b)(6) hospital. At this time, i still cannot use my prosthetic full time. This injury almost caused me to get an above the knee amputation. (b)(4) claims they are not at fault. Two other amputees have suffered the same injuries due to he same liners. Dates of use: (b)(6) 2011. Never had therapy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5021296 |
| MDR Report Key | 2163508 |
| Date Received | 2011-07-07 |
| Date of Report | 2011-07-07 |
| Date of Event | 2010-02-28 |
| Date Added to Maude | 2011-07-20 |
| 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 | 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 | ALPHA LINER |
| Generic Name | ALPHA LINER |
| Product Code | IPM |
| Date Received | 2011-07-07 |
| Lot Number | H352-6396 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OHIO WILLOW WOOD |
| Manufacturer Address | 15441 SCIOTO DARBY RD. MOUNT STERLING OH 43143 US 43143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2011-07-07 |