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U.S. Department of Health and Human Services

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

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C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT® ACELLULAR COLLAGEN BIOMESH Back to Search Results
Catalog Number 481068
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Pain (1994); Urinary Retention (2119); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
January 2017 bimonthly asr report. (b)(4). The total number of events for product classification code ftm is (b)(4). Qty (b)(4)- pelvisoft acellular collagen biomesh; qty (b)(4)- pelvisoft acellular collagen biomesh, 4cm x 7cm; qty (b)(4)- pelvisoft acellular collagen biomesh, 6cm x 8cm; qty (b)(4)- pelvisoft acellular collagen biomesh, 8cm x 12cm. 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. Sample not returned.
 
Event Description
January 2017 bimonthly asr report.
 
Manufacturer Narrative
(b)(4). 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.
 
Manufacturer Narrative
(b)(4).
 
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Brand NamePELVISOFT® ACELLULAR COLLAGEN BIOMESH
Type of DevicePELVISOFT® ACELLULAR COLLAGEN BIOMESH
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
unit 1
covington GA 30014
Manufacturer (Section G)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
unit 1
covington GA 30014
Manufacturer Contact
angela robinson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key6248905
MDR Text Key64729263
Report Number1018233-2017-00092
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Attorney
Type of Report Initial,Followup,Followup
Report Date 08/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2011
Device Catalogue Number481068
Device Lot Number08B12-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/17/2016
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 Treatment Data
Date Received: 01/13/2017 Patient Sequence Number: 1
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