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 05/10/2021

Event Type  Injury  

Manufacturer Narrative

As reported, 4 days post implant of the bard/davol perfix plug, the patient experienced redness, swelling, pain and a "mass"; was treated with anti-infection medications and recovered. Based on the information provided, no conclusion can be made. 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 september, 2020. In regards to the infection, the warnings section of the ifu 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

Per nmpa ((b)(6) fda): as reported, the patient underwent left indirect inguinal hernia repair under aseptic conditions with implant of a bard/davol perfix plug on (b)(6) 2021. It was reported that the patient experienced post-operative complications including local redness, swelling, pain and "mass" on (b)(6) 2021. As reported, the patient was treated with anti-infection medications, local hot compress and the patient recovered on (b)(6) 2021.

• 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: 12289226
• MDR Text Key: 265437048
• Report Number: 1213643-2021-20238
• 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: foreign,other,user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0112780
• Device Lot Number: HUEV1632
• Was Device Available for Evaluation?: No

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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: 08/06/2021 Patient Sequence Number: 1