InjuryMNG
FEMOSOFT URETHRAL INSERT
Received Apr 11, 2003 · Event occurred Feb 14, 2003
Report 2130787-2003-00005 · MDR key 455032
Device
Generic name
Transurethral Occlusion Device
Manufacturer
Rochester Medical CorporationModel number
FEMSOFT INSERTCatalog number
71201
Lot number
*
Product problems
- Reaction
Patient
62 YR
- Pain
- Burning Sensation
- Treatment with medication(s)
Narrative
Description of Event or Problem
PATIENT REPORTED EPISODE OF BURING/PAIN WITH URINATION. PATIENT SELF MEDICATED WITH ANTIBIOTIC FOR 5 DAYS. PATIENT REPORTED EPISODE TO CLINICAL COORDINATOR AT NEXT SCHEDULED FOLLOW-UP VISIT.