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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 LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 3DMAX LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117321
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/16/2021
Event Type  malfunction  
Manufacturer Narrative
As reported, something like a desiccant was found in the 3dmax light package. The packaging and material in question were not returned for evaluation. Based on the information provided and not having the sample to evaluate, no conclusion can be made. Review of manufacturing records indicate 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 for this manufacturing lot of (b)(4) units released for distribution in november, 2020. Should additional information be provided, a supplemental mdr will be submitted. Not returned - remains implanted.
 
Event Description
As reported, on (b)(6) 2021 when or staff opened the package of 3dmax light mesh desiccant like material was allegedly found in the sterilized package. It was also reported that there was no damage noticed on the package and the mesh was used on the patient. There was no reported patient injury.
 
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Brand Name3DMAX LIGHT
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 Key12132016
MDR Text Key260528291
Report Number1213643-2021-20178
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K091659
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial
Report Date 06/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117321
Device Lot NumberHUEV0919
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/18/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/24/2020
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: 07/07/2021 Patient Sequence Number: 1
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