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

Catalog Number 0117080

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Discomfort (2330)

Event Date 10/09/2021

Event Type  Injury  

Manufacturer Narrative

As reported post-implant of the bard/davol perfix plug light, the patient experienced foreign body sensation.It was reported that the patient continues postoperative anti-inflammatory treatment.Additional information has been requested.Based on the available information, no conclusion can be made.No lot number was provided; therefore, a review of the manufacturing records is not possible.

Event Description

As per nmpa ((b)(4)): as reported, the patient was hospitalized for a right groin oblique and was implanted with a bard/davol perfix light plug on (b)(6) 2021.It was reported that on (b)(6) 2021, the patient was experienced foreign body sensation at the implantation site but the surrounding soft tissues had no redness, swelling and pain, the dressing outside the incision was dry, and there was no bleeding or exudation.It was also reported the patient continues postoperative anti-inflammatory treatment.

• Brand Name: PERFIX PLUG LIGHT
• 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: 13124787
• MDR Text Key: 283300836
• Report Number: 1213643-2021-20494
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K092032
• 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
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 0117080
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Sex: Male