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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 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.
 
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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
angela robinson
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key7534585
MDR Text Key108949718
Report Number1018233-2018-01789
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
Report Date 05/22/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2013
Device Catalogue Number481068
Device Lot Number10B02-1
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 Received03/07/2018
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 Treatment Data
Date Received: 05/22/2018 Patient Sequence Number: 1
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