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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 Problem Defective Device (2588)
Patient Problems Fistula (1862); Inflammation (1932); Obstruction/Occlusion (2422)
Event Date 02/24/2015
Event Type  Injury  
Manufacturer Narrative

The patient's attorney alleges the patient experienced pain, infection, obstruction, fistula, fluid build up, perforation and adhesions. The medical records provided did not mention any type of obstruction, infection, perforation or adhesions related to the mesh, however, adhesions is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the instructions-for-use as a possible complication. In regards to the allegation of infection, the warning section of the instructions-for-use states "if an infection develops, treat the infection aggressively. The prosthesis may not have to be removed. An unresolved infection, however, may require removal of the prosthesis. ¿ without a lot number a review of the manufacturing records could not be conducted. With the current information available, no definitive conclusion can be made as to the extent that the device may have caused or contributed to post op complications experienced by the patient. If additional event and/or evaluation information is obtained, a follow up 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 to manufacturer.

 
Event Description

The following is based on a review of medical records and the attorney's legal claim provided to davol by the patient's attorney: ni/ni/ni - patient underwent primary closure of a parastomal hernia. On (b)(6) 2009 - the patient was diagnosed with a recurrent parastomal hernia. The patient underwent recurrent parastomal hernia repair with implant of a bard serpamesh ip device. On (b)(6) 2015 - the patient was diagnosed with a fistula of the intestine, excluding the anus and rectum and underwent a revision of her colostomy and removal of the sepramesh ip. Per the operative details "anteriorly at the fistula site, we could see mesh tails. The mesh was excised. Dissection was then carried out, taking down all the incorporated mesh. The stoma was completely released from the fascia and the wounds were curetted and any unincorporated mesh was removed. " it is alleged by the patient's attorney that between 2009 and 2014 the patient continued to seek treatment for complications resulting from the serpamesh ip, including pain, infection, intestinal blockage/obstruction, fluid build-up and drainage and adhesion. It is further alleged that in (b)(6) 2014 the patient was hospitalized due to alleged infection which was "serious, life-threatening and painful. " the sepramesh ip device was alleged to have cut into the patient's intestines and internal organs and had caused further and additional medical problems, including a "fistula of intestine" from the abnormal adhesion of tissues.

 
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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
steven figueroa
100 crossings blvd.
warwick, RI 02886
4018258460
MDR Report Key7150658
MDR Text Key95911681
Report Number1213643-2017-01115
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK063739
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 12/28/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/28/2017
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2017
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: 12/28/2017 Patient Sequence Number: 1
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