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 Impaired Healing (2378); Fluid Discharge (2686)

Event Date 05/17/2021

Event Type  Injury  

Manufacturer Narrative

As reported, the patient experienced fluid discharge, impaired wound healing and underwent removal of the bard/davol perfix plug.Additional information has been requested.Based on the information provided to date, no conclusion can be made.Review of manufacturing records indicate 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 252 units released for distribution in (b)(6) 2020.Should additional information be provided, a supplemental mdr will be submitted.

Event Description

As per nmpa (b)(6): on (b)(6) 2021 the patient underwent left side refractory indirect inguinal hernia plug tension-free repair with implant of a bard/davol perfix plug under spinal anesthesia.On (b)(6) 2021 exudation from the incision occurred eight days after the operation, the patient visited the outpatient department and was given additional dressing.As reported, the exudation continued to increase, which was considered to be caused by hernia rejection.On (b)(6) 2021 the patient was re-admitted to the hospital as the incision healed poorly.On (b)(6) 2021 the patient underwent left indirect inguinal hernia plug removal under combined spinal epidural anesthesia.

• 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: 12048280
• MDR Text Key: 257704293
• Report Number: 1213643-2021-20154
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0112780
• Device Lot Number: HUES0214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/23/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2020
• 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): Hospitalization; Required Intervention