MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-12-05 for MYSELF * manufactured by Deschutes Medical Products Inc..
[581114]
I was using the "myself" biofeedback device according to the directions. That is pumping air into the sensor until the lcd display tells me to stop. Then tighening muscles until the biofeedback display tells me to relax. When doing this i felt a sudden pain and a twinge. A lump protruded low on my abdomen. I have seen a doctor about this, it is an inguinal hernia.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1041260 |
| MDR Report Key | 790818 |
| Date Received | 2006-12-05 |
| Date of Report | 2006-12-05 |
| Date of Event | 2006-08-01 |
| Date Added to Maude | 2006-12-07 |
| 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 | PATIENT |
| 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 | MYSELF |
| Generic Name | MYSELF |
| Product Code | HCC |
| Date Received | 2006-12-05 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | PAT |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 793739 |
| Manufacturer | DESCHUTES MEDICAL PRODUCTS INC. |
| Manufacturer Address | 1101 S.W. EMKAY DR SUITE 104 BEND OR 97702 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-12-05 |