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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT SURGICAL MESH Back to Search Results
Catalog Number 0117070
Device Problem Material Frayed (1262)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2021
Event Type  malfunction  
Event Description
As reported, after opening the package of a bard/davol perfix light plug on (b)(6) 2021, the mesh was noted to be frayed. The mesh was not used on the patient. There was no reported patient injury.
 
Manufacturer Narrative
As reported, perfix light plug was found to be frayed upon opening the package. The subject device was returned for evaluation. Initial evaluation finds the sample to be unused with no evidence of excessive handling or manipulation with no visible contamination found. Visual evaluation finds that one of the monofilament threads of the mesh structure may have become untied / loosened resulting in what looks like frayed material. The sample evaluation is ongoing at this time. When sample evaluation is completed, a supplemental mdr will be submitted to document the result of sample evaluation. Review of manufacturing records indicates the product was manufactured to specification. To date, this is the only complaint reported for this manufacturing lot of 525 units released for distribution in june, 2021.
 
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Brand NamePERFIX PLUG 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 Key13124782
MDR Text Key283304823
Report Number1213643-2021-20484
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K092032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117070
Device Lot NumberHUFS0159
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/31/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/26/2021
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: 12/31/2021 Patient Sequence Number: 1
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