MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT® ACELLULAR COLLAGEN BIOMESH

Catalog Number 481812

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

Patient Problems Pain (1994); Distress (2329); Discomfort (2330); Deformity/ Disfigurement (2360)

Event Date 04/06/2021

Event Type  Injury  

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue the alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials which states the following: precautions: pelvisofttm biomesh is for single-patient use only and is to be implanted surgically.If either the outer polyester/polyethylene pouch or the inner foil pouch has been perforated or torn in shipment or storage, then the enclosed pelvisofttm biomesh should not be used.Pelvisofttm biomesh should be hydrated or moist when the package is opened.Dehydrated or dry tissue should not be implanted.2348, 1994, 2371, 2519, 2564, 2330, 2329, 2360 =¿nl¿.

Event Description

It was reported by the patient's attorney that as a result of having the product implanted the patient has experienced physical pain, suffering, permanent injury, disability, discomfort, mental and physical pain, distress, disfigurement, and underwent multiple invasive and risky mesh removal or correction surgeries.

• Brand Name: PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Type of Device: PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 14073568
• MDR Text Key: 288987778
• Report Number: 1018233-2022-90011
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/11/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2009
• Device Catalogue Number: 481812
• Device Lot Number: 06B22-9
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Device Age: 6 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 04/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2006
• 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: PELVISOFT® ACELLULAR COLLAGEN BIOMESH
• Patient Outcome(s): Required Intervention
• Patient Sex: Female