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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. -1213643 KUGEL PATCH SURGICAL MESH Back to Search Results
Catalog Number 0010101
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/15/2021
Event Type  malfunction  
Event Description
As reported, a small "ant-like insect" was noted near the center of the bard/davol kugel patch immediately after opening the sterilized package on (b)(6) 2021. As reported, that a second kugel patch was used to complete procedure. There was no reported patient injury.
 
Manufacturer Narrative
At this time no conclusion can be made. Photos were provided depicting the product carton and the opened inner sterile pouch which contains the kugel patch. Seen in the photo showing the mesh in the opened pouch is a small foreign material in the center of the mesh as reported. The foreign material appears black in color. Review of the photo can confirm the presence of a foreign material on the mesh in the opened pouch. Identification of the type or source of the material cannot be determined at this time. It is reported that the subject device is being returned for evaluation, however has not yet been received. If/when the sample is received and evaluated a supplemental emdr will be submitted. A review of the manufacturing records was performed and found that the lot was manufactured to specification. To date, this is the only complaint reported for this manufacturing lot of (b)(4) units released for distribution in april, 2020.
 
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Brand NameKUGEL PATCH
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 Key12782839
MDR Text Key282099245
Report Number1213643-2021-20397
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K963141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number0010101
Device Lot NumberHUEQ0281
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
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: 11/09/2021 Patient Sequence Number: 1
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