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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX; SURGICAL MESH Back to Search Results
Catalog Number 0115321
Device Problem Device Contaminated During Manufacture or Shipping (2969)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/23/2021
Event Type  malfunction  
Manufacturer Narrative
Based on the information available at this time, no conclusion can be made.As reported, when the instructions-for-use (ifu) were taken out of the 3dmax mesh package, a cocoon was found on the ifu.As reported the sample is not available for return.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in september 2020.This investigation is ongoing; a semdr will be submitted at the close of this investigation.
 
Event Description
As per (b)(6): on (b)(6) 2021, the patient underwent a hernia repair using a bard/davol 3dmax mesh.As reported, the operating room nurse checked the product packaging and expiration date; no abnormalities were observed and the mesh was sent to the operating table for use.When the user manual (instructions-for-use) was taken out from the packaging box, it was found that there was a cocoon in the manual.The procedure was completed by using another mesh.There was no patient injury.
 
Event Description
As per nmpa (china fda): on (b)(6) 2021, the patient underwent a hernia repair using a bard/davol 3dmax mesh.As reported, the or nurse checked the product packaging and expiration date; no abnormalities were observed and the mesh was sent to the operating table for use.When the user manual (instructions-for-use) was taken out from the packaging box, it was found that there was a cocoon in the manual.The procedure was completed by using another mesh.There was no patient injury.Addendum: additional information provided states that the product had been stored at the user facility for a ¿long time.¿.
 
Manufacturer Narrative
Based on the information available at this time, no conclusion can be made.As reported, when the instructions-for-use (ifu) were taken out of the 3dmax mesh package, a cocoon was found on the ifu.As reported the sample is not available for return.Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in september, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the investigation results.The sample was discarded and as reported, photos were not taken prior to discarding the product.Additional information provided states that the product had been stored at the user facility for a ¿long time¿, however storage conditions were not provided.Based on the information provided and no sample available to evaluate, no conclusions can be made.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 - sample discarded.
 
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Brand Name
3DMAX
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC. -1213643
100 crossings blvd.
warwick RI 02886
MDR Report Key12059166
MDR Text Key259028218
Report Number1213643-2021-20160
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741030741
UDI-Public(01)00801741030741
Combination Product (y/n)N
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,o
Type of Report Initial,Followup
Report Date 06/24/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0115321
Device Lot NumberHUEV0193
Was Device Available for Evaluation? No
Date Manufacturer Received06/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age58 YR
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