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 Problem Purulent Discharge (1812)

Event Date 10/31/2021

Event Type  Injury  

Manufacturer Narrative

As reported, post-implant of the perfix plug, the patient experienced pus discharge and underwent subsequent surgical intervention for mesh removal.Included in the information provided were two perfix plug lot numbers (hudt2151, hudv1905), the information as reported indicates the issue was associated to one device.However, it is unclear as to which lot number is associated to the event, as such the manufacturing records for both lot numbers were reviewed as part of this investigation.To date there have been no other reported complaints for either of these lot numbers.Based on the information provided, no conclusion can be made.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Mesh explanted.

Event Description

As per nmpa ((b)(4)): as reported, during a right-side inguinal hernia repair procedure on (b)(6) 2021, the patient was implanted with a bard/davol perfix plug.The hernia ring filler was used to repair the hernia sac of size about 8x7cm.It was reported that the patient was discharged on (b)(6) 2021.As reported, the patient experienced repeated pus and discharge from the incision and debridement and drainage were performed in the outpatient clinic and still the wound could not heal.As reported, the doctor suspected that the patient was allergic to the patch.It was reported that on (b)(6) 2021, the patient underwent "right inguinal incision debridement plus patch removal.¿ it was reported that on (b)(6) 2021, the patient's incision healed well.

Event Description

As per nmpa (china fda): as reported, during a right-side inguinal hernia repair procedure on (b)(6) 2021, the patient was implanted with a bard/davol perfix plug.The hernia ring filler was used to repair the hernia sac of size about 8x7cm.It was reported that the patient was discharged on (b)(6) 2021.As reported, the patient experienced repeated pus and discharge from the incision and debridement and drainage were performed in the outpatient clinic and still the wound could not heal.As reported, the doctor suspected that the patient was allergic to the patch.It was reported that on (b)(6) 2021, the patient underwent "right inguinal incision debridement plus patch removal.¿ it was reported that on (b)(6) 2021, the patient's incision healed well.

Manufacturer Narrative

As reported, post-implant of the perfix plug, the patient experienced pus discharge and underwent subsequent surgical intervention for mesh removal.Included in the information provided were two perfix plug lot numbers (hudt2151, hudv1905), the information as reported indicates the issue was associated to one device.However, it is unclear as to which lot number is associated to the event, as such the manufacturing records for both lot numbers were reviewed as part of this investigation.To date there have been no other reported complaints for either of these lot numbers.Based on the information provided, no conclusion can be made.Addendum: h.11: this is an addendum to the initial mdr submitted to report the additional information provided and corrected lot number (hudv1905).The additional details provided does not change the initial determination, 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.Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned - mesh explanted.

• 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: 13235082
• MDR Text Key: 284515385
• Report Number: 1213643-2021-20502
• 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: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• 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: HUDV1905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2019
• 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