MAUDE Adverse Event Report: ROCHESTER MEDICAL CORP. FEMSOFTINSERT

Catalog Number 72201

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Urinary Tract Infection (2120); Hematuria (2558)

Event Date 01/26/2015

Event Type  Injury  

Event Description

It was reported that the device was found inside the patient's bladder during a routine ultrasound.A previous ultrasound in (b)(6) 2014 did not show the device.The patient had experienced a uti and some bleeding prior to discovery, but the patient and her mother had been unaware that the device was missing until the scan.The patient had been prescribed the device was treatment for stress urinary incontinence, as the patient has been diagnosed with spinia bifida with neurogenic bladder and bowel, and is not confirmed to a wheelchair.The patient has been inserting the device herself for several months, prior to this her mother had been inserting them for her.The device was removed from the bladder via cystoscopy.A large stone was noted on one end.Antibiotics were given prophylactically.

Manufacturer Narrative

The device was not returned for evaluation, however a photo of the device following removal from the patient was made available.The lot number is unknown; therefore, the device history record could not be reviewed.(b)(4).

• Brand Name: FEMSOFTINSERT
• Manufacturer (Section D): ROCHESTER MEDICAL CORP.; stewartville MN
• Manufacturer (Section G): ROCHESTER MED. CORP.; one rochester med. dr.; stewartville MN 5597
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4539093
• MDR Text Key: 5545373
• Report Number: 1018233-2015-00052
• Device Sequence Number: 1
• Product Code: OCK
• Combination Product (y/n): N
• PMA/PMN Number: P990002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 72201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 4161025 WELLSPECT LOFRIC SENSE CH10; INTERMITTENT CATHETERS
• Patient Outcome(s): Required Intervention
• Patient Age: 13 YR