MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM

Catalog Number 486010

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

Patient Problems Erosion (1750); Fatigue (1849); Incontinence (1928); Pain (1994); Abnormal Vaginal Discharge (2123); Discomfort (2330); Cramp(s) /Muscle Spasm(s) (4521)

Event Type  Injury  

Manufacturer Narrative

No sample received.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted, the patient has experienced pain, discomfort, urinary problems, dyspareunia, additional surgeries, erosion, injury and urinary incontinence.Product was used for therapeutic treatment.Per additional information received on 19nov2021, the patient has experienced cramping, tenderness on right side and pressure, foul discharge, fatigue and required additional surgical and non-surgical interventions.

• Brand Name: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Type of Device: AVAULTA ANTERIOR BIOSYNTHETIC SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12882212
• MDR Text Key: 281321688
• Report Number: 1018233-2021-80095
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/31/2011
• Device Catalogue Number: 486010
• Device Lot Number: ZGC00002
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Female