MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-05-13 for FEMSOFT INSERT 71201 manufactured by Rochester Medical Corp..
[16259896]
The pt contacted her femsoft insert distributor and told them she had a burning sensation for three weeks. The distributor customer service rep encouraged the pt to contact her physician and to discontinue using the femsoft inserts. The pt stated she started using the femsoft inserts (b)(6) 2010 and discontinued usage of the inserts (b)(6) 2010. The pt contacted a rochester medical customer service rep on (b)(6) 2010 and stated had a kidney infection. The pt reported she visited a physician and was prescribed cephlax and bactrim. The pt stated that she has no control over her bladder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2010-00002 |
| MDR Report Key | 1692197 |
| Report Source | 07 |
| Date Received | 2010-05-13 |
| Date of Report | 2010-05-06 |
| Date of Event | 2010-05-05 |
| Date Mfgr Received | 2010-05-06 |
| Device Manufacturer Date | 2009-12-29 |
| Date Added to Maude | 2012-03-14 |
| 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 | FEMSOFT INSERT |
| Generic Name | URETHRAL INSERT |
| Product Code | OCK |
| Date Received | 2010-05-13 |
| Catalog Number | 71201 |
| Lot Number | 53500598 |
| Device Expiration Date | 2014-12-01 |
| Operator | LAY USER/PATIENT |
| 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. Other | 2010-05-13 |