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

Catalog Number 0112720

Device Problems Migration or Expulsion of Device (1395); Folded (2630)

Patient Problems Pain (1994); Disability (2371)

Event Date 05/09/2017

Event Type  Injury  

Manufacturer Narrative

Currently, it is unknown to what extent the device may have caused or contributed to the reported event.The information provided alleges that the patient "underwent an additional surgery to revise the positioning of the mesh, which had migrated and folded in on itself".Medical records are not available at this time.Based on the limited information provided at this time, no conclusions can be made.Should additional information be provided 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.Not returned.

Event Description

The following was alleged by the patient's attorney: (b)(6) 2012: the patient underwent surgery for repair of an umbilical hernia.A bard/davol flat mesh, (b)(4), lot number huvi0528 was implanted to repair the hernia defect.(b)(6) 2017: the patient underwent an additional surgery to revise the positioning of the mesh, which had migrated and folded in on itself.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective marlex.

• 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: francesca santamaria ; 100 crossings blvd.; warwick, RI 02886 ; 4018258538
• MDR Report Key: 7249436
• MDR Text Key: 99271032
• Report Number: 1213643-2018-00219
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016561
• UDI-Public: (01)00801741016561
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PREAMENDMENT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 02/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Catalogue Number: 0112720
• Device Lot Number: HUVI0528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2011
• 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): Required Intervention; Disability