URETHRAL STENT 5377240

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-25 for URETHRAL STENT 5377240 manufactured by Surgi-tech.

Event Text Entries

[2786] Patient to hospital for routine urethral stent replacement which the patient usually has replaced every three months. The patient was previously seen in may 1992, and the stent was noted to have malfunctioned in august 1992. Upon cystoscope examination approximately 1/3 of stent placed 5/11/92 was in renal pelvis, 2/3 was in bladder. The patient did undergo unplanned surgery for removal and replacement of the stentdevice labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. Imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: component failure. Conclusion: device failure related to patient condition. Certainty of device as cause of or contributor to event: yes. Corrective actions: other. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4597
• MDR Report Key: 4597
• Date Received: 1993-02-25
• Date of Report: 1992-09-10
• Date of Event: 1992-08-21
• Report Date: 1992-09-10
• Date Reported to FDA: 1992-09-10
• Date Added to Maude: 1993-05-28
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: URETHRAL STENT
• Product Code: MER
• Date Received: 1993-02-25
• Catalog Number: 5377240
• Lot Number: G452-90H/G379-90E
• Operator: OTHER
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 4316
• Manufacturer: SURGI-TECH

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-02-25