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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 5959680
Device Problem Insufficient Information
Event Type  Injury  
Manufacturer Narrative

Based on the information available at this time, no definitive conclusions can be made. A review of the manufacturing records was performed and found that the lot was manufactured to specification. Recurrence and adhesion are both known inherent risks of the surgery and are listed in the adverse reaction section of the ifu as possible complications. The operative report from the implant procedure was provided confirming the implant of a sepramesh ip device. A video alleged to be of the revision procedure was provided for review. There was no visualization of a sepramesh ip in the video, nor did it show any mesh attached to the colon. A mesh was observed in the video, however it was not a sepramesh ip device. It is not known if the patient was implanted with other mesh products. If additional information is obtained, a supplemental mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned.

 
Event Description

It is reported that in 2013 the patient was implanted with a bard sepramesh ip to repair an abdominal hernia. As reported three years later the patient underwent an additional procedure due to a recurrence of hernia. During this procedure it is reported that the mesh was found to be attached to the colon.

 
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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
laura berg
100 crossings blvd.
warwick , RI 02886
4018258462
MDR Report Key5939829
Report Number1213643-2016-00433
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation Physician
Type of Report Initial
Report Date 08/15/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date08/28/2014
Device Catalogue Number5959680
Device LOT NumberHUWH1086
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received08/15/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/30/2012
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: 09/09/2016 Patient Sequence Number: 1
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