MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-05-23 for SUPER POLIGRIP manufactured by Super Poligrip Glaxo Smith Kline Consumer Healthcare Lp.
[631315]
Pt was totally disabled. He was diagnosed with neuropathy 2 years ago and treated with medicine. He has no feeling in his hands and is using walker to keep from falling. He said, he deteriorated after using this device. He has pain while standing or sitting. He said, he has lost his short-term memory and he can't recall many things. He said my life is done, and people think that i am contagious and they don't want to come to see me. I still can drive, but i take my daughter with me in case i fall. I have fallen many times before. He said that, he has read an article about his problem, that 25% of people die from that each year. He said he is going to get an attorney to look at the report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5001930 |
| MDR Report Key | 855071 |
| Date Received | 2007-05-23 |
| Date of Report | 2007-05-23 |
| Date Added to Maude | 2007-06-18 |
| 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 |
| Health Professional | 0 |
| 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 | SUPER POLIGRIP |
| Generic Name | NONE |
| Product Code | KOM |
| Date Received | 2007-05-23 |
| ID Number | 1P16901 |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 847822 |
| Manufacturer | SUPER POLIGRIP GLAXO SMITH KLINE CONSUMER HEALTHCARE LP |
| Manufacturer Address | PITTSBURG PA 15230 US |
| Brand Name | SUPER POLIGRIP |
| Generic Name | NONE |
| Product Code | KOM |
| Date Received | 2007-05-23 |
| ID Number | 98078XA |
| Operator | LAY USER/PATIENT |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 2 |
| Device Event Key | 847823 |
| Manufacturer | SUPER POLIGRIP GLAXO SMITH KLINE CONSUMER HEALTHCARE LP |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-23 |