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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 0010103
Device Problems Patient-Device Incompatibility (2682); Patient Device Interaction Problem (4001)
Patient Problems Adhesion(s) (1695); Obstruction/Occlusion (2422); No Information (3190)
Event Date 02/25/2021
Event Type  Injury  
Manufacturer Narrative
As reported, the patient had symptoms similar to his crohn's disease symptoms post implant of kugel patch. Based on the information provided, no conclusion can be made as to the degree to which the bard device, may be causing or contributing the patients reported symptoms. 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 april, 2012. Note, the date of implant is estimated as (b)(6) 2012 based on the information received as a specific implant date was not provided; the date of event is provided as a best estimate based on the date of awareness of the reported event. Should additional information be provided a supplemental mdr will be submitted.
 
Event Description
As reported, the patient was implanted with a bard kugel mesh in 2012 and has been having some symptoms similar to the patient's crohn's disease symptoms. As reported, the patient went to the doctor who did not find anything on the x-ray.
 
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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 Key11085363
MDR Text Key224244411
Report Number1213643-2020-20087
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K963141
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 10/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/28/2017
Device Catalogue Number0010103
Device Lot NumberHUWD0417
Was Device Available for Evaluation? No
Date Manufacturer Received10/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/24/2012
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: 12/28/2020 Patient Sequence Number: 1
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