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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. ONFLEX SURGICAL MESH Back to Search Results
Catalog Number UNKAA107
Device Problem No Apparent Adverse Event (3189)
Patient Problem Hernia (2240)
Event Type  Injury  
Manufacturer Narrative

The surgeon initially reported a possible failure (recurrence) of the onflex mesh following implant. After reviewing his notes the surgeon states that the failure was not associated with the onflex mesh. As such this complaint is unconfirmed. This complaint is unconfirmed, however, regarding recurrence the warning section of the instructions-for-use states, "to prevent recurrences when repairing hernias, the mesh should be large enough to provide sufficient overlap beyond the margins of the defect. If fixation is used, careful attention to mesh fixation placement and spacing will help prevent excessive tension or gap formation between the mesh and fascial tissue. " no lot number has been provided, without this information a review of the manufacturing records cannot be conducted. Should additional information be obtained, a supplemental emdr 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.

 
Event Description

It was initially reported that the patient experienced a hernia recurrence following the implant of a davol onflex mesh that was possibly related to the mesh. After reviewing his notes the surgeon states that the failure was not associated with the onflex mesh. No additional information was provided.

 
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Brand NameONFLEX
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 sundberg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key7754428
MDR Text Key116156056
Report Number1213643-2018-02626
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK142711
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/06/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/06/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA107
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
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: 08/06/2018 Patient Sequence Number: 1
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