MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2010-06-29 for FEMSOFT INSERT 71202 manufactured by Rochester Medical Corp.
[1343022]
It was reported that the customer was using femsoft urethral insert samples provided to her by her physician. The customer reported that she experienced irritation the first time she used to femsoft inserts. The customer reported that she quit using the femsoft inserts on (b)(6) 2010 due to the customer feeling like she had an infection. The customer reported that she went to a local clinic and was diagnosed with a urinary tract infection. The customer reported the physician prescribed an antibiotic for the customer to treat the uti.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2010-00001 |
| MDR Report Key | 1748844 |
| Report Source | 07 |
| Date Received | 2010-06-29 |
| Date of Report | 2010-04-27 |
| Date of Event | 2010-04-15 |
| Date Mfgr Received | 2009-04-27 |
| Device Manufacturer Date | 2007-08-06 |
| 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 | 2010-06-29 |
| Catalog Number | 71202 |
| Lot Number | 53500458 |
| Device Expiration Date | 2012-08-13 |
| 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 | 2010-06-29 |