• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

C.R. BARD, INC. (COVINGTON) -1018233 PELVISOFT ACELLULAR COLLAGEN BIOMESH Back to Search Results
Catalog Number 481812
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Fistula (1862); Constipation (3274)
Event Type  Injury  
Manufacturer Narrative
Nov 2017 bimonthly asr. (b)(4). The total number of events for product classification code ftm is 9. Qty 1- pelvisoft acellular collagen biomesh. Qty 2- pelvisoft acellular collagen biomesh, 4cm x 7cm. Qty 2- pelvisoft acellular collagen biomesh, 6cm x 8cm. Qty 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 received.
 
Event Description
Nov 2017 bimonthly asr.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key7032446
MDR Text Key92039122
Report Number1018233-2017-05873
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 11/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2009
Device Catalogue Number481812
Device Lot Number06B21-9
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 Received08/24/2017
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: 11/15/2017 Patient Sequence Number: 1
-
-