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

Catalog Number 0112760

Device Problem Insufficient Information (3190)

Patient Problems Pain (1994); Hernia (2240)

Event Type  Injury  

Manufacturer Narrative

Based on the information available at this time, no conclusions can be made. Recurrence is listed in the adverse reaction section of the ifu as a possible complication. A review of the manufacturing records was performed and found that the lot was manufactured to specification. If additional information is provided, a supplemental mdr will be submitted. Note: 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. Remains implanted.

Event Description

The following was reported to davol and is not based on medical documentation: on (b)(6) 2013 - the patient was diagnosed with a right inguinal hernia and underwent repair with implant of a bard perfix plug. Ni/ni/2013 - the patient had an md office follow up exam and the surgeon removed the staples. During this procedure the surgeon decided to add an additional staple to the patient's wound. On (b)(6) 2014 - the patient had an md office exam with complaints of severe pain and a right inguinal bulge. The surgeon indicated there appears to be a recurrence of the hernia and the patient would most likely need additional surgery. The patient did not want to follow through with an additional procedure. The patient was prescribed narcotic pain medication to help relieve the pain. Ni/ni/2015 - the patient continued to experience pain and was treated at a rehabilitation facility due to a dependence on narcotic pain medication and addiction to non prescribed pain medication and/or illicit drugs. The patient was prescribed suboxone to help manage the pain and addiction to long term use of narcotic pain medication and continues to follow up with a primary care physician to help manage the pain. The patient does not want to follow up with a surgeon or have any additional surgical intervention performed at this time.

• 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: laura berg ; 100 crossings blvd.; warwick, RI 02886 ; 4018258462
• MDR Report Key: 6212201
• MDR Text Key: 63480887
• Report Number: 1213643-2016-00592
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: CONSUMER

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/13/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 12/29/2016
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 04/30/2018
• Device Catalogue Number: 0112760
• Device LOT Number: HUXD0736
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/13/2016
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 04/20/2013
• 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: 12/29/2016 Patient Sequence Number: 1