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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; Insufficient Information
Event Type  Injury  
Manufacturer Narrative

The complainant has indicated that no additional information would be provided at this time. Based on the information available, no conclusions can be made. A lot number was not provided, therefore a review of the manufacturing records could not be conducted. Recurrence is identified in the adverse reaction section of the ifu as a possible complication. If additional information is obtained, a supplemental mdr will be submitted. This mdr represents the sepramesh reported to have been implanted in 2011. A separate mdr was sent to document the bard mesh reported to have been implanted in 2009. 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. Device remains implanted.

 
Event Description

It has been reported that in 2009 the patient underwent abdominal hernia repair and was implanted with a bard mesh device. As reported the hernia recurred and in 2011 the patient twice underwent emergency surgery and was implanted with a bard sepramesh. Following the surgery in 2011 it is reported that the patient experienced complications of bleeding in which a drain had to be placed, numbness of the leg (unspecified side), hernia recurrence and most recently in 2016 a bowel obstruction and hospitalization.

 
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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
jan ling
100 crossings blvd.
warwick , RI 02886
8015652663
MDR Report Key6234259
Report Number1213643-2017-00015
Device Sequence Number1
Product CodeFTL
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 09/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
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 Received08/22/2016
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: 01/09/2017 Patient Sequence Number: 1
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