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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. MESH ¿ COMPOSIX KUGEL SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. MESH ¿ COMPOSIX KUGEL SURGICAL MESH Back to Search Results
Catalog Number UNKAA016
Device Problems Defective Device (2588); Patient Device Interaction Problem (4001)
Patient Problem Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
No conclusions can be made. The patient's attorney alleges adverse patient outcome associated with the hernia mesh used to treat the patient. The patient's attorney alleges that the patient had subsequent surgical intervention; however, no details have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. This emdr represents the bard/davol mesh ¿ composix kugel (device #1). An additional emdr was submitted to represent the bard/davol perfix plug (device #2). Should additional information be provided, a supplemental emdr will be submitted.
 
Event Description
Attorney alleges that the patient underwent surgery for implant of unspecified bard/davol composix kugel hernia patch and perfix plug on (b)(6) 2003 and/or (b)(6) 2005. As reported, the patient is making a claim for an adverse patient outcome both devices. Attorney alleges that the patient had subsequent surgical intervention due to the hernia mesh device. It is also alleged that the patient sustained personal injury, experienced emotional distress and the device was defective.
 
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Brand NameMESH ¿ COMPOSIX KUGEL
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
DAVOL INC., SUB. C.R. BARD, INC.
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
4018258495
MDR Report Key14254514
MDR Text Key290417187
Report Number1213643-2022-93346
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061314
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
Report Date 04/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA016
Was Device Available for Evaluation? No
Date Manufacturer Received04/26/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/29/2022 Patient Sequence Number: 1
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