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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Type  Injury  
Manufacturer Narrative
The reported event could not be confirmed. No sample was returned for evaluation and the lot number is unknown. 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. Device problem code: (b)(4).
 
Event Description
The patient's attorney alleged a deficiency against the device. Additional information has been requested, but not yet received.
 
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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
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 Key12916025
MDR Text Key281594511
Report Number1018233-2021-80106
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K031332
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Event Location Hospital
Date Manufacturer Received11/19/2021
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: 12/02/2021 Patient Sequence Number: 1
Treatment
ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM; AVAULTA PLUS® BIOSYNTHETIC SUPPORT SYSTEM-ANTERIOR; PELVICOL® ACELLULAR COLLAGEN MATRIX
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