MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. PERFIX PLUS

Catalog Number UNKAA053

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

Patient Problems Nerve Damage (1979); Pain (1994); Disability (2371); Ambulation Difficulties (2544)

Event Date 01/10/2013

Event Type  Injury  

Event Description

The following info was provided via (b)(4): the pt has alleged that on (b)(6) 2007 he was implanted with a perfix plug and patch during left inguinal hernia repair.Following implant, the pt reports that he began to experience pain and by 2010 he was put on disability as the "hernia plug" damaged the nerves of the pelvis which caused severe pain that radiated from the pelvis down the pts left thigh.Pt alleges he "finally found a surgeon who would remove the mesh" and on (b)(6) 2013 the pt underwent explant of the perfix plug and patch.The pt alleges that when the mesh was examined by the surgeon it was noted that the mesh had "folded over" and "was out of place" and that the mesh caused so much damage the surgeon could only recognize one nerve in that area.The pt alleges he is left with crippling pain and no sensation in half of his pelvis.Pt alleges that he was inactive and barely walking from 2010-2013 due to the problems experienced and has undergone "multiple" unspecified surgeries including the implant of a nerve stimulator to reduce the pain.

Manufacturer Narrative

Based on the currently available info we are unable to verify the alleged condition of the device, and we are unable to determine to what extent, if any, the bard device may have caused or contributed to the events as alleged.No medical records have been provided to date, additional info has been requested from the pt.No lot number has been provided therefore a review of the mfg records could not be conducted.If additional info is obtained, a follow up mdr will be submitted.

• Brand Name: PERFIX PLUS
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; warwick RI
• Manufacturer (Section G): BARD SHANNON LIMITED; lot#1, road#3 km 79.7; san geronimo industrial park; humacao PR 00791
• Manufacturer Contact: laura berg ; 100 crossings boulevard; warwick, RI 02886 ; 8005566756
• MDR Report Key: 3817619
• MDR Text Key: 4401190
• Report Number: 1213643-2014-00123
• Device Sequence Number: 1
• Product Code: FTL
• 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: Other,Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKAA053
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 04/29/2014
• 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): Required Intervention; Disability