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

Catalog Number	0117080
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, 2 days 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 or Problem Description
As per nmpa (china fda): as reported, the patient was hospitalized for a right indirect inguinal hernia repair and was implanted with a bard/davol perfix light plug on (b)(6) 2021.It was reported that on (b)(6) 2021, the patient felt that the foreign body sensation at the patch implantation site and also the flexion and movement of the right lower limb were aggravated, there was no redness, swelling and pain, and the external dressing of the incision was dry and there was no exudation.It was also reported that the patient continues postoperative anti-inflammatory treatment.

• Brand Name: PERFIX PLUG LIGHT
• Common Device Name: 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: 13124785
• Report Number: 1213643-2021-20495
• Device Sequence Number: 19959702
• Product Code: FTL
• UDI-Device Identifier: 00801741030970
• UDI-Public: (01)00801741030970
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K092032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/15/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0117080
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2021
• Initial Report FDA Received Date: 12/31/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male