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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH

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DAVOL INC., SUB. C.R. BARD, INC. SEPRAMESH IP SURGICAL MESH Back to Search Results
Catalog Number UNKAA066
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Death (1802); Injury (2348)
Event Type  Death  
Manufacturer Narrative
At this time no conclusions can be made regarding the bard/davol sepramesh ip (device #2) used to treat the patient. The patient's attorney did allege surgical intervention and death; however, no details have been provided. No medical records, autopsy, or death certificate have been provided. No lot number has been provided; therefore, a review of the manufacturing records is not possible. Should additional information be provided a supplemental emdr will be submitted. This emdr represents the bard/davol sepramesh ip (device #2). An additional emdr was submitted to represent the bard/davol composix kugel (device #1). Device evaluated by mfr: not returned.
 
Event Description
Attorney alleges that on (b)(6) 2005 or (b)(6) 2010, the patient underwent surgery for implant of an unspecified bard/davol composix kugel hernia patch (device #1) or an unspecified bard/davol sepramesh ip (device #2). It is alleged that the patient had subsequent surgical intervention due to the hernia mesh device. As reported, the patient is making a claim for an adverse patient outcome against the composix kugel hernia patch (device #1) and the sepramesh ip (device #2). As reported, the attorney alleges wrongful death, the product is defective, and that the patient experienced emotional distress.
 
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Brand NameSEPRAMESH IP
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
roxanne tidwell
100 crossings blvd.
warwick, RI 02886
8015652300
MDR Report Key8605660
MDR Text Key144884194
Report Number1213643-2019-03805
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K063739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 05/13/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/13/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKAA066
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
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: 05/13/2019 Patient Sequence Number: 1
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