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 Codes	Wound Dehiscence (1154); Pain (1994)
Date of Event	07/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As reported, two months post implant of the phasix mesh, the patient experienced a postoperative superficial wound dehiscence and associated pain, when the stitches in a small section of the incision had ¿popped open.¿ this adverse event is reported to have resolved with no treatment.Based on the information provided, a definitive conclusion cannot be made.Wound dehiscence and pain are known inherent risks of surgery and are identified as potential complications in the adverse reaction section of the instructions-for-use, supplied with the device.Review of manufacturing records confirms product was manufactured to specification.This mdr represents the adverse event of wound dehiscence.An additional mdr was submitted to document an adverse event of seroma.
Event or Problem Description
As reported in (b)(4): on (b)(6) 2021, the patient underwent a laparoscopic colectomy and a bard/davol phasix mesh was trimmed and placed in onlay fashion.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 superficial wound dehiscence.This ae is reported to have resolved with no treatment provided, on (b)(6) 2021.It was also reported that the patient had pain associated with skin dehiscence.Upon inspection it appeared that the stitches had "popped open" in a small section of incision.Study clinician noted no concerns and healing was going well still.The adverse event has been assessed as moderate severity and as not a serious adverse event (sae) or an unanticipated adverse device effect (uade) by the study group.The adverse event has been assessed per 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: 14140601
• Report Number: 1213643-2022-00157
• Device Sequence Number: 4293908
• 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: 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): 03/29/2022

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: 07/28/2022
• Device Catalogue Number: 1190820
• Device Lot Number: HUEV1403
• 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: 11/02/2020
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 96 KG