MAUDE Adverse Event Report: CR BARD TRANSVAGINAL MESH

Device Problem Insufficient Information (3190)

Patient Problems Anemia (1706); Diarrhea (1811); Incontinence (1928); Lupus (1956); Neuropathy (1983); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120)

Event Date 10/16/2002

Event Type  Injury  

Event Description

The reporter stated that after the catheter was taken out, she started having the following abnormalities: while she was at a gas station pumping gas, urine burst out of her as how a pregnant woman's baby water breaks, non-stop.She also had radiating pain, urinary retention, uti, lupus, vaginal shortening, anemic, neuropathy and has been having diarrhea continuously for the past 18 months.The reporter strongly recommends that no one should fall a victim as she did, and she needs financial assistance.

• Brand Name: TRANSVAGINAL MESH
• Type of Device: TRANSVAGINAL MESH
• Manufacturer (Section D): CR BARD
• MDR Report Key: 5878319
• MDR Text Key: 52294149
• Report Number: MW5064101
• Device Sequence Number: 1
• Product Code: FTL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR