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

Catalog Number 481068

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

Patient Problems Nausea (1970); Vomiting (2144); Injury (2348)

Event Type  Injury  

Manufacturer Narrative

(b)(6) 2018 bimonthly asr report.Exemption (b)(4).The total number of events for product classification code ftm is 4.Qty 1- pelvisoft acellular collagen biomesh, 4cm x 7cm; qty 3- pelvisoft acellular collagen biomesh, 6cm x 8cm.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.(b)(4).Sample not received.

Event Description

(b)(6) 2018 biomonthly 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: 7534585
• MDR Text Key: 108949718
• Report Number: 1018233-2018-01789
• 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: Attorney
• Type of Report: Initial
• Report Date: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 481068
• Device Lot Number: 10B02-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/07/2018
• 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