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U.S. Department of Health and Human Services

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

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DAVOL INC., SUB. C.R. BARD, INC. BARD SOFT MESH SURGICAL MESH Back to Search Results
Catalog Number UNKAA069
Device Problems Hole In Material (1293); Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/05/2016
Event Type  Malfunction  
Manufacturer Narrative

Although, requested product identifiers were not provided, therefore a review of the manufacturing records is not possible. Without having the lot number or sample returned for evaluation, at this time no definitive conclusions can be made regarding the root cause for the reported event. 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. Patient details are unobtainable due to the privacy laws in (b)(6). Device remains implanted.

 
Event Description

The following was reported to davol: it was reported that during a bilateral laparoscopic inguinal hernia repair using the tep technique, the surgeon was attempting to secure a bard soft mesh with a bard sorbafix fixation device, however the tack fired through the mesh, creating a hole and didn't hold it in place. The mesh was left in place and fixated with a non bard/davol fixation device. There was no patient injury reported.

 
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Brand NameBARD SOFT 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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5614207
MDR Text Key43841074
Report Number1213643-2016-00175
Device Sequence Number1
Product Code FTL
Combination Product (Y/N)N
Reporter Country CodeCA
PMA/PMN NumberK052155
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 04/05/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/28/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberUNKAA069
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received04/05/2016
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

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