STARTER KIT, SIZE 3, 1213

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-08-11 for STARTER KIT, SIZE 3, 1213 manufactured by Uromed Corp..

Event Text Entries

[15448421] Pt was diagnosed with a device migration after an ultrasound was performed on 7/23/97.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1224675-1997-00042
• MDR Report Key: 112405
• Report Source: 07
• Date Received: 1997-08-11
• Date of Report: 1997-07-25
• Date of Event: 1997-07-01
• Date Mfgr Received: 1997-07-24
• Device Manufacturer Date: 1996-10-01
• Date Added to Maude: 1997-08-14
• 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
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: STARTER KIT, SIZE 3, 1213
• Generic Name: RELIANCE
• Product Code: MNG
• Date Received: 1997-08-11
• Model Number: SIZE 3
• Catalog Number: 1213
• Lot Number: 0000000008
• ID Number: *
• Device Expiration Date: 1998-10-01
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 110344
• Manufacturer: UROMED CORP.
• Manufacturer Address: 64 A ST. NEEDHAM MA 02194 US
• Baseline Brand Name: RELIANCE
• Baseline Generic Name: URETHRAL OCCLUSION DEVICE
• Baseline Model No: SIZE 3
• Baseline Catalog No: 1203
• Baseline ID: *
• Baseline Device Family: URINARY CONTROL INSERT
• Baseline Shelf Life Contained: Y
• Baseline Shelf Life [Months]: 24
• Baseline PMA Flag: Y
• Premarket Approval: P9600
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1997-08-11