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

Catalog Number 0112780

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abscess (1690); Unspecified Infection (1930); Swelling (2091)

Event Date 09/29/2020

Event Type  Injury  

Manufacturer Narrative

As reported, the patient experienced redness, swelling and pus in the right scrotum post implant of the perfix plug.Based on the information provided to date, no conclusion can be made as to the degree to which the device, may have caused or contributed the patients reported postoperative course.As reported, the patient underwent incision and drainage of pus, treated with antibiotics and recovered.A review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of (b)(4) units released for distribution in jan 2019.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." note, the date of event ((b)(6) 2020) is estimated based on the date of implant ((b)(6) 2020) provided.Should additional information be provided, a supplemental mdr will be submitted.Not returned - remains implanted.

Event Description

As reported, per the nmpa ((b)(6) health authority), the patient underwent a hernia repair surgery for the implant of a bard/davol perfix plug on (b)(6) 2020 and on the 3rd day post-implant, the patient had redness and swelling of the right scrotum.The patient was treated with anti-infective agents, which were ineffective.Subsequently, the patient underwent incision and drainage of pus, was administered with anti-infective drugs and the patient recovered.

• 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: 11107833
• MDR Text Key: 224751304
• Report Number: 1213643-2020-20092
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2023
• Device Catalogue Number: 0112780
• Device Lot Number: HUCY1479
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2019
• 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
• Patient Age: 56 YR