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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 Material Too Rigid or Stiff (1544)
Patient Problems Adhesion(s) (1695); Pain (1994); Strangulation (2084)
Event Date 04/11/2015
Event Type  Injury  
Manufacturer Narrative
There was no contact information provided on the maude event report as such we are unable to request additional details regarding the reported event. As no lot number was provided a review of the manufacturing records could not be conducted. Adhesions is listed in the adverse reaction section of the ifu as a possible complication. The patient states on the maude event report that the fda issued a recall (2010). The only recall known in this period of time that may be relevant was for counterfeit mesh (not made by bard/davol). Based on the limit information provided, at this time no definitive conclusions can be made. If additional information is obtained, a supplemental mdr will be submitted.
 
Event Description
The following was reported to davol via maude event report mw 5061846: alleged "in (b)(6) 2010 had a inguinal hernia repaired using marlex mesh. In (b)(6)2015 was experiencing abdominal pain and after seeking the advice of a surgeon, had to have the original repair repaired. Upon removal of original mesh doctor noted that the mesh was cutting him through his glove and that the edge of the mesh was not sealed as normal mesh would be. The mesh had entangled many internal organs and cut off the blood supply to left testicle. Left testicle had to be removed 8 days later due to lack of blood supply. After this i started doing research and found out that the fda had issued a recall for the same things months prior to my original surgery. Was this mesh on the original recall or was it a new lot of mesh that had not been previously reported. ".
 
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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 berg
100 crossings blvd.
warwick, RI 02886
4018258462
MDR Report Key5706198
MDR Text Key46793642
Report Number1213643-2016-00253
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,other
Reporter Occupation Patient
Type of Report Initial
Report Date 05/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2016
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 Hospital
Date Manufacturer Received05/20/2016
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

Patient Treatment Data
Date Received: 06/08/2016 Patient Sequence Number: 1
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