FEMSOFT INSERT 71201, 71202

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2001-10-15 for FEMSOFT INSERT 71201, 71202 manufactured by Rochester Medical Corporation.

Event Text Entries

[16295036] Complained of urgency, frequency and low back discomfort. Patient treated by physician for urinary tract infection based on symptoms alone.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2130787-2001-00013
• MDR Report Key: 357097
• Report Source: 05
• Date Received: 2001-10-15
• Date of Report: 2001-10-11
• Date of Event: 2001-10-05
• Date Mfgr Received: 2001-10-11
• Date Added to Maude: 2001-10-24
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: ROB ANGLIN
• Manufacturer Street: ONE ROCHESTER MEDICAL DRIVE
• Manufacturer City: STEWARTVILLE MN 55976
• Manufacturer Country: US
• Manufacturer Postal: 55976
• Manufacturer Phone: 5075339613
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FEMSOFT INSERT
• Generic Name: FEMALE TRANSURETHRAL OCCLUSION DEVICE
• Product Code: MNG
• Date Received: 2001-10-15
• Model Number: FEMSOFT INSERT
• Catalog Number: 71201, 71202
• Lot Number: 53500095 & 53500096
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 346318
• Manufacturer: ROCHESTER MEDICAL CORPORATION
• Manufacturer Address: ONE ROCHESTER MEDICAL DRIVE STEWARTVILLE MN 55976 US
• Baseline Brand Name: FEMSOFT URETRAL INSERT
• Baseline Generic Name: FEMALE TRANSURETHRAL OCCLUSION DEVICE
• Baseline Model No: FEMSOFT INSERT
• Baseline Catalog No: 72202
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2001-10-15