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

Catalog Number	0117060
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Abscess (1690); Inflammation (1932); Pain (1994)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based on the information provided we are unable to determine to what extent, if any, the perfix light plug may have caused or contributed to the events as alleged.As reported the patient was told by a doctor that his symptoms are ¿most likely due to the mesh being attached to his nerves.¿ however, the diagnosis has not been determined.As reported the patient is going to discuss his options with another surgeon.To date no appointment has been scheduled and there has been no surgical intervention to address the patient's symptoms.At this time, no conclusion can be made.To date this is the only reported complaint for this manufacturing lot of 159 units released for distribution in november, 2016.A review of the manufacturing records was performed and found that the lot was manufactured to specification should additional information be obtained, a supplemental emdr 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 or Problem Description
It was reported that on (b)(6) 2017 the patient underwent a left inguinal hernia repair and was implanted with davol perfix light plug.As reported, the patient experienced severe pain in his left groin and underwent multiple injections of steroids for the pain and inflammation.As reported, the patient was given steroid injections for a 4 week period after implant of the perfix light plug.As reported the patient has seen several specialist since the implant for complaints of stomach pain, swelling at the bottom of the incision site as well as a reoccurring abscess with purulent discharge.As reported, the patient has seen a gastroenterologist and underwent an upper endoscopy and ct scans which were reported to be normal.As reported, the patient had last seen a doctor a few months ago and was told the issues he is experiencing are ¿most likely due to the mesh being attached to his nerves.¿ the patient reports that, he will be following up with another surgeon to discuss his options.As reported the patient has lost over 20lbs since the implant procedure.

• Brand Name: PERFIX LIGHT PLUG
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC.; 100 crossings blvd.; warwick RI 02886
• MDR Report Key: 7595657
• Report Number: 1213643-2018-01946
• Device Sequence Number: 13772443
• Product Code: FTL
• UDI-Device Identifier: 00801741030956
• UDI-Public: (01)00801741030956
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: 0117060
• Device Lot Number: HUAX2008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Weight: 67