MAUDE Adverse Event Report: UNKNOWN UNKNOWN MESH BLADDER SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Lot Number 25/03/2016

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem Radiation Burn (1755)

Event Type  Injury  

Event Description

A family member of the patient reported that the patient had an mri with their mesh bladder sling and that it burned their bladder out.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: UNKNOWN MESH BLADDER SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17533075
• MDR Text Key: 321111410
• Report Number: MW5139981
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Lot Number: 25/03/2016
• Patient Sequence Number: 1