MAUDE Adverse Event Report: DAVOL INC., SUB. C.R. BARD, INC. -1213643 PERFIX PLUG LIGHT; SURGICAL MESH

Catalog Number	0117070
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	10/07/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported, during an left inguinal hernia repair procedure on (b)(6) 2015, the patient was implanted with a bard/davol perfix light plug.It was reported that post-implant, the patient experienced pain, "feeling of mesh out of place" and abdominal discomfort.It was also reported that the patient has been dealing with gastroesophageal reflux disease (gerd) for many years.As reported, a ct scan, ultrasound, and mri was performed and there were no findings.The patient has been taking pain medication.
Additional Manufacturer Narrative
As reported, post-implant of the perfix plug light, the patient has experienced chronic pain and abdominal discomfort.Patient has undergone multiple tests with no findings and continues to seek medical assistance.Based on the available information, no conclusion can be made.Review of manufacturing records confirms product was manufactured to specification.Note, the date of event is estimated, based on the information provided.Not returned - remains implanted.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): DAVOL INC., SUB. C.R. BARD, INC. -1213643; 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: andrew topoulos ; 100 crossings blvd.; warwick, RI 02886 ; 8005566756
• MDR Report Key: 14188193
• Report Number: 1213643-2022-00186
• Device Sequence Number: 14591742
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• 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: 2015
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2022

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: 05/01/2012
• Device Catalogue Number: 0117070
• Device Lot Number: HUZF1065
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 04/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2015
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male