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

Catalog Number 0112780

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 04/12/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusion can be made.As reported, the patient experienced mild redness, swelling and pus post-implant of the perfix plug.The patient has recovered after being treated with antibiotics, and debridement and drainage of the wound.Review of manufacturing records indicate the product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.The instructions-for-use supplied with the device states "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

As per (b)(6): on (b)(6) 2021 - the patient underwent a tension-free herniorrhaphy for right refractory indirect inguinal hernia with implant of a bard/davol perfix plug.On (b)(6) 2021 - post implant, as reported, the incision had mild redness, swelling and pus.The wound recovered well after administration of anti-infection medication, debridement and drainage, and a dressing change.

• Brand Name: PERFIX PLUG
• 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: 12056634
• MDR Text Key: 258022588
• Report Number: 1213643-2021-20157
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741016622
• UDI-Public: (01)00801741016622
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K922916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: 0112780
• Device Lot Number: HUCX2968
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/11/2018
• 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