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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.
 
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.Addendum: during a laparoscopic ventral hernia repair or intraperitoneal onlay mesh technique, a hole occurred in the composix l/p during fixation.There was a 5-10 minute delay and the procedure was completed using another bard/davol capsure straight fixation device.
 
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.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the product identifier details (catalog & lot number) and additional procedure details.The additional information provided does not change the initial determination, no conclusion can be made.Review of manufacturing records indicate product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in july, 2017.Updated fields: b4, b5 (event description), d4 (medical device lot#, medical device catalog #, unique identifier (udi)#, & medical device expiration date), h4 (device manufacture date).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).Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned - remains implanted.
 
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Brand Name
MESH COMPOSIX L/P
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key11162463
MDR Text Key226569557
Report Number1213643-2021-20001
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
K061754
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
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 Expiration Date06/28/2022
Device Catalogue Number0134450
Device Lot NumberHUBT0966
Was Device Available for Evaluation? No
Date Manufacturer Received01/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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