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 Injury (2348); Blood Loss (2597); Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

May 2019 quarterly.Exemption (b)(4).The total number of events for product classification code ftm is 11.Qty 6- pelvisoft acellular collagen biomesh, qty 1- pelvisoft acellular collagen biomesh, 4cm x 7cm, qty 3- pelvisoft acellular collagen biomesh, 8cm x 12cm, qty 1- unknown bmd women's health mesh product.Sample not received.

Event Description

May 2019 quarterly asr report.

• 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: angela robinson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8598950
• MDR Text Key: 144671770
• Report Number: 1018233-2019-02438
• 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: 05/10/2019

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: No Information
• Device Expiration Date: 08/31/2011
• Device Catalogue Number: 481812
• Device Lot Number: 08B11-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 05/10/2019
• 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