MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE

Catalog Number 485054

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erosion (1750); Prolapse (2475); Dyspareunia (4505); Fecal Incontinence (4571)

Event Type  Injury  

Manufacturer Narrative

No sample received.

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received on 19nov2021, the patient has experienced vaginal mesh erosion, dyspareunia, hispareunia, recurrent stage 2 pelvic organ prolapse, defecatory dysfunction and required additional surgical and non-surgical interventions.

• Brand Name: URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
• Type of Device: URETEX TO2 URETHRAL SUPPORT SYSTEM W/HOOK NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12882217
• MDR Text Key: 281321616
• Report Number: 1018233-2021-80100
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2011
• Device Catalogue Number: 485054
• Device Lot Number: SGL00473
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM; AVAULTA POSTERIOR BIOSYNTHETIC SUPPORT SYSTEM; PELVICOL® ACELLULAR COLLAGEN MATRIX
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 68 KG