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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD FLAT MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA030
Device Problem Migration or Expulsion of Device (1395)
Patient Problems Internal Organ Perforation (1987); Pain (1994)
Event Type  Injury  
Manufacturer Narrative
There is no connection that can be made at this time between the reported post-operative complications and any problem with the bard/davol device used to treat the patient. The information provided is limited. Additional information has been requested. Based on the limited information provided to date, no conclusion can be made. Should additional information be obtained, a supplemental emdr will be submitted. The emdr represents bard/davol mesh #3, additional emdr have been submitted to represent bard/davol mesh #'s 1 and 2 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
The following was reported to davol: the patient underwent implant of an unknown bard/davol mesh (#1). As reported, the bard/davol mesh "moved. " the patient underwent additional surgery in which a second bard/davol mesh (#2) was implanted. As reported, the second bard/davol mesh "moved. " the patient underwent an additional surgery in which a third bard/davol mesh (#3) was implanted. The contact reports the third mesh has moved into the patient's bladder and states the surgeon refuses to remove the mesh as surgery would be too much of a risk.
 
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Brand NameBARD FLAT MESH
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 Key7287306
MDR Text Key100648079
Report Number1213643-2018-00340
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
PMA/PMN Number
PREAMENDMENT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient Family Member or Friend
Type of Report Initial
Report Date 02/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA030
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 Received01/29/2018
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: 02/21/2018 Patient Sequence Number: 1
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