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

Catalog Number	1190820
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, one day post implant of the phasix mesh the patient reported and was treated for pain at the incisional site.Based on the information provided, a definitive conclusion cannot be made.Pain is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use, supplied with the device as a possible complication.Review of manufacturing records confirms product was manufactured to specification.To date, this is the only reported complaint for this manufacturing lot of 28 units released for distribution in june, 2019.
Event or Problem Description
As reported per prevent clinical trial (b)(4): on (b)(6) 2020, patient underwent a laparoscopic low anterior colon resection.A bard/davol phasix mesh was trimmed and placed in onlay fashion.A 3cm overlap was achieved in all directions.The mesh was sutured in place with 1 pds absorbable monofilament suture and sorbafix fixation.On (b)(6) 2020, the patient was diagnosed with incisional pain.Pain medication was provided for pain management and the pain resolved on (b)(6) 2022.The adverse event has been assessed as moderate in severity, and as not a serious adverse event (sae) or an unanticipated adverse device effect (uade), per study group.The adverse event has been assessed per the study clinician as not related to the study device and definitely related to the index procedure.The adverse event has 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: 14113192
• Report Number: 1213643-2022-00154
• Device Sequence Number: 2096251
• Product Code: OOD
• UDI-Device Identifier: 00801741107566
• UDI-Public: (01)00801741107566
• 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: 2020
• 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): 03/29/2022

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 Expiration Date: 05/28/2021
• Device Catalogue Number: 1190820
• Device Lot Number: HUDR1444
• 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: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2019
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 103 KG