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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 0117060
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/14/2020
Event Type  malfunction  
Manufacturer Narrative
As reported, a foreign material was found on the perfix light plug. The material was removed from the device and the device was implanted into the patient. The material removed was returned for evaluation. The evaluation confirmed the material to be a piece of the monofilament used when stitching the petals of the perfix light plug together. There was no alleged detachment of the plug during use, indicating that the material found is residual from the manufacturing process likely from the when the thread is cut. Based on the investigation and returned sample evaluation, the root cause is determined to be manufacturing related. 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 manufacturing lot of (b)(4) units released for distribution in february, 2020.
 
Event Description
As reported, it was identified that while opening the package on (b)(6) 2020, a foreign material like frayed thread was found on the perfix light plug. The device was used after removing the foreign material. There was no reported patient injury.
 
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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 Key10790538
MDR Text Key214736174
Report Number1213643-2020-20033
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 foreign,health professional,o
Reporter Occupation
Type of Report Initial
Report Date 10/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0117060
Device Lot NumberHUEN0049
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/29/2020
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: 11/05/2020 Patient Sequence Number: 1
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