MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-01-16 for MYSELF manufactured by Deschutes Medical Products, Inc..
[21610629]
User described event as follows: "i was using the myself biofeedback device according the directions. That is pumping air into the sensor until the lcd display tells me to stop. Then tightening muscle unitl the biofeedback display tells me to relax. When doing this i felt a sudden pain and 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 | 3021763-2007-00001 |
| MDR Report Key | 806231 |
| Report Source | 00 |
| Date Received | 2007-01-16 |
| Date of Event | 2006-08-01 |
| Date Added to Maude | 2007-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1011 SW EMKAY DR # 104 |
| Manufacturer City | BEND OR 97702 |
| Manufacturer Country | US |
| Manufacturer Postal | 97702 |
| Manufacturer Phone | 5413850350 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MYSELF |
| Generic Name | PERINEOMETER, 884.1425 |
| Product Code | HCC |
| Date Received | 2007-01-16 |
| Model Number | NA |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 793739 |
| Manufacturer | DESCHUTES MEDICAL PRODUCTS, INC. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-01-16 |