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

Catalog Number 0117070

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Discomfort (2330)

Event Date 10/07/2015

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 289887203
• Report Number: 1213643-2022-00186
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030963
• UDI-Public: (01)00801741030963
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K092032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2012
• Device Catalogue Number: 0117070
• Device Lot Number: HUZF1065
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2015
• 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
• Patient Sex: Male