inforMED
InjuryMNG

FEMSOFT URETHRAL INSERT

Received Jul 19, 2002 · Event occurred Apr 9, 2002

Report 2130787-2002-00003 · MDR key 405746

Device

Generic name

Female Transurethral Occlusion Device

Model number

FEMSOFT INSERT

Catalog number

71201

Lot number

53500047

Product problems

  • Unknown (for use when the device problem is not known)

Patient

61 YR

  • Pain
  • Urinary Tract Infection
  • Burning Sensation
  • Treatment with medication(s)

Narrative

Description of Event or Problem

PATIENT REPORTED HAVING SYMPTOMS OF UTI (PAIN AND BURNING WITH URINATION) IN FALL 2001. PATIENT DID NOT NOTIFY CLINICAL STUDY COORDINATOR UNTIL NEXT SCHEDULED FOLLOWUP VISIT. SYMPTOMS RESOLVED WITH MACRODANTIN.