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

Catalog Number 0112970

Device Problems Device Issue (2379); Defective Device (2588)

Patient Problems Pain (1994); Hernia (2240); Disability (2371)

Event Date 12/07/2010

Event Type  Injury  

Manufacturer Narrative

To date, limited information has been provided.Based on the information available at this time, we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.Hernia recurrence is a known inherent risk of hernia repair surgery and is identified in the adverse reaction section of the ifu as a possible complication.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.Not returned.

Event Description

It is alleged by the patients attorney that on (b)(6) 2010, the patient underwent surgery for repair of an incarcerated left inguinal hernia.As reported, a bard/davol perfix plug, reference number 0112970, lot number huta0663 was implanted to repair the hernia defect.It is alleged that on (b)(6) 2010, the patient underwent an additional surgery to repair recurrent hernia after the perfix plug failed and to remove the perfix plug.As alleged, the patient was injured severely and permanently and has suffered and will continue to suffer physical pain due to the alleged defective perfix plug.

• Brand Name: PERFIX PLUG
• 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: jessica messier ; 100 crossings blvd.; warwick, RI 02886 ; 4018258720
• MDR Report Key: 7268439
• MDR Text Key: 99983843
• Report Number: 1213643-2018-00278
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016677
• UDI-Public: (01)00801741016677
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2014
• Device Catalogue Number: 0112970
• Device Lot Number: HUTA0663
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2009
• 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