MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AVAULTA SOLO¿ SYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE; AVAULTA SOLO MESH

Catalog Number 486100

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Muscle Spasm(s) (1966); Urinary Tract Infection (2120); Discomfort (2330)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that a surgery was performed on (b)(6) 2011 by associate professor (b)(6) , of (b)(6).The patients diagnosis was cystocele.After approximately 1.5 years of adverse events, chronic urinary tract infections, spottings, bilateral trochanteritis, lumbar discomfort, spasm of the right chianerv, and tear tightness.The mesh eroded with ejecting "pieces" through the vagina.The patient was continuously treated with nitrofurantoin, 1 tablet / day.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the unknown avaulta - bard product ifus are found to be adequate based on past reviews.

Event Description

It was reported that a surgery was performed on (b)(6)2011 by associate professor folke flam, of stockholm st.Göran hospital.The patients diagnosis was cystocele.After approximately 1.5 years of adverse events, chronic urinary tract infections, spottings, bilateral trochanteritis, lumbar discomfort, spasm of the right chianerv, and tear tightness.The mesh eroded with ejecting "pieces" through the vagina.The patient was continuously treated with nitrofurantoin, 1 tablet / day.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the unknown avaulta - bard product ifus are found to be adequate based on past reviews.Corrections: patient identifier, brand name,and pma/510k.

Event Description

It was reported that a surgery was performed on (b)(6)2011 by associate professor folke flam, of stockholm st.Göran hospital.The patients diagnosis was cystocele.After approximately 1.5 years of adverse events, chronic urinary tract infections, spottings, bilateral trochanteritis, lumbar discomfort, spasm of the right chianerv, and tear tightness.The mesh eroded with ejecting "pieces" through the vagina.The patient was continuously treated with nitrofurantoin, 1 tablet / day.

• Brand Name: AVAULTA SOLO¿ SYNTHETIC SUPPORT SYSTEM - ANTERIOR, STERILE
• Type of Device: AVAULTA SOLO MESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7794739
• MDR Text Key: 117567902
• Report Number: 1018233-2018-03640
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 486100
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/27/2018
• Initial Date FDA Received: 08/17/2018
• Supplement Dates Manufacturer Received: 09/19/2018; 11/28/2018
• Supplement Dates FDA Received: 09/20/2018; 12/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention