MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2011-10-20 for FEMSOFT 71201 manufactured by Rochester Medical Corp..
[2219710]
The patient received some femsoft urethral inserts samples to try from her clinician. The clinician inserted a sample. The patient left the clinician's office and later reported a slight sensation she could not describe. The patient visited an emergency room thinking the femsoft device had migrated. An x-ray was taken in the emergency room, but the device could not be seen in the x-ray. The patient then contacted customer service and the patient was provided a list of registered femsoft clinicians for her area. The patient visited one of the registered clinicians and the device was removed from the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2130787-2011-00002 |
| MDR Report Key | 2309996 |
| Report Source | 04 |
| Date Received | 2011-10-20 |
| Date of Report | 2011-10-14 |
| Date of Event | 2008-03-27 |
| Date Mfgr Received | 2008-03-27 |
| Date Added to Maude | 2012-07-12 |
| 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 |
| Generic Name | URETHRAL INSERT |
| Product Code | OCK |
| Date Received | 2011-10-20 |
| Model Number | 71201 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2011-10-20 |