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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION SEPRAMESH IP SURGICAL MESH

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GENZYME CORPORATION SEPRAMESH IP SURGICAL MESH Back to Search Results
Catalog Number 5959360
Device Problems Defective Device (2588); Insufficient Information (3190)
Patient Problems Adhesion(s) (1695); Laceration(s) (1946); Disability (2371)
Event Date 03/30/2011
Event Type  Injury  
Manufacturer Narrative
To date, limited information has been provided. Based on the limited information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged. Regarding adhesions, the warning section of the ifu states "there may be a possibility for adhesion formation when the prosthesis is placed in direct contact with the bowel or viscera. 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 alleged by the patients attorney that on (b)(6) 2009, the patient underwent surgery for repair of an incisional type hernia. As reported, a bard/davol sepramesh ip, reference number 5959360, lot number wbsls234 was implanted to repair the hernia defect. It is alleged that on (b)(6) 2011, the patient underwent an additional surgery to remove the abdominal wall mesh, repair of bladder wall laceration, and lysis of adhesions. As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective separmesh ip.
 
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Brand NameSEPRAMESH IP
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
GENZYME CORPORATION
80 new york ave
framingham MA 01701
Manufacturer (Section G)
GENZYME CORPORATION
80 new york ave
framingham MA 01701
Manufacturer Contact
jessica messier
100 crossings blvd.
warwick, RI 02886
4018258720
MDR Report Key7153953
MDR Text Key96018661
Report Number1213643-2017-01137
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 Attorney
Type of Report Initial
Report Date 12/29/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number5959360
Device Lot NumberWBSLS234
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/05/2017
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: 12/29/2017 Patient Sequence Number: 1
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