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

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.".

• Brand Name: BARD FLAT MESH
• Type of Device: SURGICAL 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 Key: 5706198
• MDR Text Key: 46793642
• Report Number: 1213643-2016-00253
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• 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 Received: 06/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/20/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability