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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH
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DAVOL INC., SUB. C.R. BARD, INC. 3DMAX; SURGICAL MESH Back to Search Results
Catalog Number 0115322
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
No conclusion can be made.As reported the sample is available for return.However, to date has not been received.A photo was provided of the 3dmax mesh package containing the mesh product.However, the photo was taken at a distance and does not allow for confirmation of the alleged "piece of fuzz in the sterile packaging." without having the sample to review, root cause determination cannot be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of (b)(4) units released for distribution in february 2015.Should the sample be received and an evaluation is completed a supplemental emdr will be submitted at that time.Not returned.
 
Event Description
It was reported that a small piece of fuzz was noted in the sterile packaging.The product was not opened or used on a patient as the fuzz inside the packaging was noticed prior to opening the package.
 
Manufacturer Narrative
No conclusion can be made.As reported the sample is available for return.However, to date has not been received.A photo was provided of the 3dmax mesh package containing the mesh product.However, the photo was taken at a distance and does not allow for confirmation of the alleged "piece of fuzz in the sterile packaging." without having the sample to review, root cause determination cannot be made.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date this is the only reported complaint for this production lot of 65 units released for distribution in (b)(6) 2015.Should the sample be received and an evaluation is completed a supplemental emdr will be submitted at that time.Addendum (b)(6) 2020: this is an addendum to the initial emdr to document the receipt of the sample and the results of the sample evaluation performed at the manufacturing facility.The sample evaluation confirms the foreign material to be a hair.The hair was found to be sealed within the product packaging and would have undergone sterilization with the product, as such caused no risk of contamination.The root cause is determined to be a manufacturing related.All appropriate manufacturing personnel have been provided awareness notification.Updated fields: b4, d4, g4, g7, h2, h3, h6, h10.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.
 
Event Description
It was reported that a small piece of fuzz was noted in the sterile packaging.The product was not opened or used on a patient as the fuzz inside the packaging was noticed prior to opening the package.
 
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Brand Name
3DMAX
Type of Device
SURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
100 crossings blvd.
warwick RI 02886
MDR Report Key9740954
MDR Text Key180833287
Report Number1213643-2020-01543
Device Sequence Number1
Product Code FTL
UDI-Device Identifier00801741030772
UDI-Public(01)00801741030772
Combination Product (y/n)N
PMA/PMN Number
K081010
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/28/2020
Device Catalogue Number0115322
Device Lot NumberHUZA0753
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Initial Date Manufacturer Received 01/30/2020
Initial Date FDA Received02/21/2020
Supplement Dates Manufacturer Received03/10/2020
Supplement Dates FDA Received04/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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