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

Catalog Number	1191025
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Pain (1994)
Date of Event	02/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, post-implant of the phasix mesh, the patient experienced postoperative incisional pain and itching, these symptoms resolved with no treatment.Based on the information provided, a definitive conclusion cannot be made.Pain is a known inherent risk of surgery and is identified as a potential complication in the adverse reaction section of the instructions-for-use, supplied with the device.Review of manufacturing records confirms product was manufactured to specification.
Event or Problem Description
As reported (b)(4): on (b)(6) 2021, patient underwent a laparoscopic colectomy and a bard/davol phasix mesh was trimmed and placed in onlay fashion with a 3cm overlap in all directions.The mesh was sutured in place with non-bard/davol absorbable monofilament sutures and a bard/davol sorbafix fixation device.On (b)(6) 2021, the patient was diagnosed with incisional pain.The patient also experienced incisional site itching in (b)(6) 2021.These aes were reported to have resolved with no treatment provided, on (b)(6) 2021.The adverse events have been assessed as mild severity and as not a serious adverse event (sae) or an unanticipated adverse device effect (uade) by the study group.The adverse events have been assessed per study clinician as not related to the study device and definitely related to the index procedure.The adverse events have been assessed per cec clinician as possibly related to the study device and definitely related to the index procedure.

• Brand Name: PHASIX MESH
• 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: 14140610
• Report Number: 1213643-2022-00155
• Device Sequence Number: 4025287
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161424
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Other,Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2022
• Device Catalogue Number: 1191025
• Device Lot Number: HUEV1630
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/22/2022
• Initial Report FDA Received Date: 04/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2020
• 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: Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 127 KG