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

Catalog Number	0117080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported on (b)(6) 2023, the patient underwent high ligation of the right inguinal hernia sac and tension-free hernia repair under general anesthesia with perfix light plug implant.After the operation, the patient had swelling and pain in the spermatic cord above the scrotum.It was reported that no additional treatment was required, and the patient¿s status is reported to be good.
Additional Manufacturer Narrative
Based on the information provided, no conclusions can be made.As reported, the patient experience pain and swelling post implant of perfix light plug.This postoperative event required no treatment, and the patient is reported to be in good condition.Postoperative pain is a known inherent risk of surgery and is identified in the adverse reactions section of the instructions-for-use provided with the device as a possible complication.The information provided does not suggest or indicate that a malfunction of the implant used to treat the patient caused or contributed to the patient¿s postoperative symptoms.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in july 2022.Note: section a through f - the information provided by bd 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 bd.H3 other text : not returned.

• 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: 17981531
• Report Number: 1213643-2023-00383
• Device Sequence Number: 2453758
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0117080
• Device Lot Number: HUGS2261
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Initial Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2022
• 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: Other
• Patient Sex: Male