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

Catalog Number 0112750

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Pain (1994); Burning Sensation (2146)

Event Date 02/13/2020

Event Type  Injury  

Event Description

As reported, during an unspecified procedure on (b)(6) 2020, the patient was implanted with a bard/davol perfix plug. It was reported that post implant of the mesh, the patient experienced a burning sensation and pain in the groin area where the mesh was placed. As reported on (b)(6) 2022, a cat scan was performed to identify the causing factor of the pain.

Manufacturer Narrative

As reported, post-implant of the perfix plug, the patient experienced a burning sensation and pain. Patient has undergone a cat scan to identify the causing factor of the pain; the results have not been made unavailable at this time. Based on the information provided, no conclusion can be made. Review of manufacturing records confirms the product was manufactured to specification. To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in dec, 2018. Not returned - remains implanted.

• 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: 14279267
• MDR Text Key: 290662326
• Report Number: 1213643-2022-00200
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K922916
• 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,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 0112750
• Device Lot Number: HUCX2280
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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: 05/04/2022 Patient Sequence Number: 1