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 Purulent Discharge (1812); Impaired Healing (2378); Swelling/ Edema (4577)

Event Date 10/12/2021

Event Type  Injury  

Manufacturer Narrative

Based on the information provided, no conclusion can be made. As reported, one month post implant of the perfix plug, the patient was re-admitted to the hospital with redness, swelling and pus on the surgical mouth. Review of manufacturing records confirms product was manufactured to specification, with no indication of a manufacturing related cause for the event reported. To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in july, 2019. Should additional information be provided a supplemental mdr will be submitted. Not returned - mesh explanted.

Event Description

As reported, the patient underwent tension-free inguinal hernia repair on (b)(6) 2021 and was implanted with a bard/davol perfix plug. After surgery, the wound healed well and the patient was discharged from the hospital on (b)(6) 2021. It was reported that on (b)(6) 2021, the patient was admitted to the hospital due to redness, swelling and pus on the surgical mouth. After debridement and dressing change, the incision was exuded and did not heal. It was reported that on (b)(6) 2021, the doctor decided to remove the implanted mesh and the mesh removal surgery was performed on (b)(6) 2021. Purulent fluid was noted in the implant. The wound healed well after the operation.

• 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: 12787452
• MDR Text Key: 280586249
• Report Number: 1213643-2021-20402
• Device Sequence Number: 1
• Product Code: FTL
• 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: Other,Foreign,Health Professional,User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0112780
• Device Lot Number: HUDS2345
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 11/10/2021 Patient Sequence Number: 1