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

Catalog Number	1191530
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hernia (2240); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being "definitely" related to the study device, however, based on the information provided, no conclusion can be made.As reported the phasix mesh was used to reinforce soft tissue following a colostomy reversal procedure, and approximately 18 months post implant the patient developed a hernia at the site of the repair.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This mdr represents the ae of hernia.An additional mdr (1213643-2021-20147) was previously submitted to represent an ae of seroma.
Event or Problem Description
As reported per prevent clinical trial (b)(4): on (b)(6) 2021, the subject patient underwent primary laparotomy-open colostomy reversal procedure performed in open fashion, during which a phasix mesh was trimmed and placed in onlay technique.A 3cm overlap in all directions was achieved.The phasix mesh was secured in place with suture fixation only.The fascia was closed with ethicon 1 pds suture, and the skin was fully closed with staples.The subject patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2022, the patient was diagnosed with a hernia at stoma site reducible and minimally symptomatic.The reported adverse event (ae) has been assessed per the clinician as definitely related to the study device and definitely related to the procedure.The ae has been assessed as moderate in severity with no additional medical or surgical intervention required at this time.As reported, the ae does not meet the criteria of a sae (serious adverse event), or a uade (unanticipated adverse device event).
Event or Problem Description
As reported per prevent clinical trial dvl-he-018: on (b)(6) 2021, the subject patient underwent primary laparotomy-open colostomy reversal procedure performed in open fashion, during which a phasix mesh was trimmed and placed in onlay technique.A 3cm overlap in all directions was achieved.The phasix mesh was secured in place with suture fixation only.The fascia was closed with ethicon 1 pds suture, and the skin was fully closed with staples.The subject patient was discharged from the hospital on (b)(6) 2021.On (b)(6) 2022, the patient was diagnosed with a hernia at stoma site reducible and minimally symptomatic.The reported adverse event (ae) has been assessed per the clinician as definitely related to the study device and definitely related to the procedure.The ae has been assessed as moderate in severity with no additional medical or surgical intervention required at this time.As reported, the ae does not meet the criteria of a sae (serious adverse event), or a uade (unanticipated adverse device event).Addendum per additional information: the subject patient ae (hernia at the stoma site) has been clinically reassessed as not related to the study device.As reported, the phasix mesh was placed in a different anatomical location (midline index incision) not the stoma site where the ae presented.
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being "definitely" related to the study device, however, based on the information provided, no conclusion can be made.As reported the phasix mesh was used to reinforce soft tissue following a colostomy reversal procedure, and approximately 18 months post implant the patient developed a hernia at the site of the repair.A review of the manufacturing records was performed and found that the lot was manufactured to specification.This mdr represents the ae of hernia.An additional mdr (1213643-2021-20147) was previously submitted to represent an ae of seroma.Addendum: h11: this supplemental mdr is submitted to report additional/corrected information regarding the ae provided.The clinician has assessed the patient¿s postoperative course (hernia) as being "not related" to the study device as the noted hernia was at the stoma site whereas the phasix mesh was placed in a different anatomical location (midline index incision).Note: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : not returned - remains implanted.

• 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: 16272161
• Report Number: 1213643-2023-00032
• Device Sequence Number: 7549027
• Product Code: OOD
• UDI-Device Identifier: 00801741107610
• UDI-Public: (01)00801741107610
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2023

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: 08/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDU0528
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 02/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2019
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 60 KG