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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH COMPOSIX L/P SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 MESH COMPOSIX L/P SURGICAL MESH Back to Search Results
Catalog Number 0134450
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2020
Event Type  Malfunction  
Manufacturer Narrative

As reported, during fixation, the bard/davol composix l/p mesh was damaged by the bard/davol capsure fasteners and remains implanted. Additional information has been requested. Based on the information provided, no conclusion can be made. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This mdr represents the bard/davol composix l/p mesh (device #2). An additional mdr was submitted to represent the bard/davol capsure (device #1). Should additional information be provided, a supplemental mdr will be submitted. Not returned. Remains implanted.

 
Event Description

As reported, during a laparoscopic procedure on (b)(6) 2020, while deploying the first 10 fasteners of the bard/davol capsure straight fixation device with appropriate counter-pressure, no fasteners were able to fixate into the bard/davol composix l/p mesh correctly. Cracking sound was not heard; the fasteners penetrated the mesh and tissues partly, hence the surgeon found it difficult to remove the loose fasteners as it was damaging the mesh and tissues. There was no reported patient injury. The surgeon is an existing user of the capsure device.

 
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Brand NameMESH COMPOSIX L/P
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
BARD SHANNON LIMITED -3005636544
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
andrew topoulos
100 crossings blvd.
warwick, RI 02886
8005566756
MDR Report Key11162463
MDR Text Key226569557
Report Number1213643-2021-20001
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberK061754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/18/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number0134450
Device LOT NumberHUBT0966
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2021
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/14/2017
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: 01/13/2021 Patient Sequence Number: 1
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