US RELIANCE SIZE/PK UNK SIZE 5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 1997-10-16 for US RELIANCE SIZE/PK UNK SIZE 5 manufactured by Uromed Corp..

Event Text Entries

[71393] Patient reported after several months of pain, a device was found adhered to her bladder wall.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1224675-1997-00049
• MDR Report Key: 126905
• Report Source: 04,07
• Date Received: 1997-10-16
• Date of Report: 1997-10-06
• Date of Event: 1997-07-03
• Date Mfgr Received: 1997-10-03
• Date Added to Maude: 1997-10-21
• 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: US RELIANCE SIZE/PK UNK
• Generic Name: RELIANCE
• Product Code: MNG
• Date Received: 1997-10-16
• Model Number: SIZE 5
• Catalog Number: UNK
• Lot Number: UNK
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 124197
• 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 5
• Baseline Catalog No: 1205
• 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	1997-10-16