MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-11-30 for FEM SOFT UNK manufactured by Rochester Medical Corp.
[2509543]
A report was received from a distributor. The report states that the pt's husband had called the distributor concerning a refund for some femsoft product that had been returned to the distributor months ago. The pt's husband stated that the pt had internal bleeding from using a femsoft device. The pt's husband stated that the pt's physician told her to stop using the product. The pt's husband stated that the pt had a cut at the base of the pt's bladder and large blood clots were observed. The pt's husband stated the pt collapsed at a doctor's office and had lost 2 liters of blood causing her to be rushed to the emergency room. The pt's husband stated his wife was in an intensive care unit for 3 days. No samples or product info was available due to the return of the unused product to the distributor and the discarding the used femsoft device. No physician or hospital info was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2011-00004 |
| MDR Report Key | 2359817 |
| Report Source | 08 |
| Date Received | 2011-11-30 |
| Date of Report | 2011-11-30 |
| Date Mfgr Received | 2011-11-11 |
| Date Added to Maude | 2011-12-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROB ANGLIN |
| Manufacturer Street | ONE ROCHESTER MEDICAL DR. |
| Manufacturer City | STEWARTVILLE MN 55976 |
| Manufacturer Country | US |
| Manufacturer Postal | 55976 |
| Manufacturer Phone | 5075339613 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FEM SOFT |
| Generic Name | URETHRAL INSERT |
| Product Code | OCK |
| Date Received | 2011-11-30 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ROCHESTER MEDICAL CORP |
| Manufacturer Address | STEWARTVILLE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2011-11-30 |