MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-08-04 for MINNOVA * 199269-001 manufactured by Empi.
[508916]
Patient was treating pelvic floor pain (pre-existing) and after using the minnova her condition became worse. Patient said after using the device twice, she is now experiencing a lot more pain and a burning sensation. Urologist who prescribed the device recommended that the patient see a pelvic floor specialist. Patient saw pelvic floor specialist and patient said, the pelvic floor specialist told her that, he believes that device caused damage to her vaginal tissue and patient was given a prescription for co-estra.
Patient Sequence No: 1, Text Type: D, B5
[7793737]
The investigation has not been completed at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182686-2006-00004 |
| MDR Report Key | 747371 |
| Report Source | 07 |
| Date Received | 2006-08-04 |
| Date of Report | 2006-07-27 |
| Date of Event | 2006-02-28 |
| Date Mfgr Received | 2006-06-14 |
| Device Manufacturer Date | 2005-12-01 |
| Date Added to Maude | 2006-08-15 |
| 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 | 599 CARDIGAN RD |
| Manufacturer City | ST PAUL MN 55126 |
| Manufacturer Country | US |
| Manufacturer Postal | 55126 |
| Manufacturer Phone | 8003282536 |
| Manufacturer G1 | EMPI |
| Manufacturer Street | CLEAR LAKE INDUSTRIAL PARK |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MINNOVA |
| Generic Name | INCONTINENCE |
| Product Code | KPI |
| Date Received | 2006-08-04 |
| Returned To Mfg | 2006-06-26 |
| Model Number | * |
| Catalog Number | 199269-001 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 735145 |
| Manufacturer | EMPI |
| Manufacturer Address | * ST. PAUL MN 55126 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2006-08-04 |