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 Code	Hernia (2240)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post implant of the phasix mesh, the patient was diagnosed with abdomen bulge/hernia.The clinician has assessed the patient¿s hernia recurrence as being definitely related to the study device and to the procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists hernia recurrence as a possible complication.Review of manufacturing records shows product was manufactured to specification.This mdr represents the ae of hernia recurrence.Additional mdr was previously submitted to represent ae of seroma.Note, the date of event is considered as the best estimate (b)(6) 2022), based on the available information.Not returned - remains implanted.
Event or Problem Description
As reported per clinical trial (b)(4): (b)(6) 2021 - the subject patient underwent an open resection of a pelvic mass, during which a bard/davol phasix mesh onlay was placed and secured in place with absorbable monofilament 2.0 vicryl sutures.The surgery was done without trimming the phasix mesh and the midline fascia was completely closed.A 3cm overlap in all directions was achieved.Prophylactic antibiotic rocephin were used perioperatively.Skin closure was achieved with long-term absorbable suture and surgical glue.It was reported that the subject patient was diagnosed with abdomen bulging/hernia in aug-2022.As reported, the subject patient will undergo scan on (b)(6) 2022.As reported, the reported adverse event (abdomen bulge/hernia) has been assessed per clinician as definitely related to the study device and definitely related to the procedure and recovering/resolving.The ae has been assessed as mild in severity.The reported ae does not meet the definition of a sae (serious adverse event) or uade (unanticipated adverse device event).
Additional Manufacturer Narrative
As reported, post implant of the phasix mesh, the patient was diagnosed with abdomen bulge/hernia.The clinician has assessed the patient¿s hernia recurrence as being definitely related to the study device and to the procedure.However, based on the information provided, no conclusion can be made.Hernia recurrence is a known inherent risk of hernia repair surgery.The adverse reactions section of the instructions-for-use, supplied with the device lists hernia recurrence as a possible complication.Review of manufacturing records shows product was manufactured to specification.Note, the date of event is considered as the best estimate (15-aug-2022), based on the available information.Addendum: this supplemental report is submitted to document the patient underwent an mri scan confirming the presence of a ventral hernia.Based on the additional information received, there is no change to the initial determination, no conclusions can be made.This supplemental mdr represents the ae of hernia recurrence.An additional mdr was previously submitted to represent the ae of seroma.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.
Event or Problem Description
As reported per clinical trial dvl-he-018: (b)(6) 2021 - the subject patient underwent an open resection of a pelvic mass, during which a bard/davol phasix mesh onlay was placed and secured in place with absorbable monofilament 2.0 vicryl sutures.The surgery was done without trimming the phasix mesh and the midline fascia was completely closed.A 3cm overlap in all directions was achieved.Prophylactic antibiotic rocephin were used perioperatively.Skin closure was achieved with long-term absorbable suture and surgical glue.It was reported that the subject patient was diagnosed with abdomen bulging/hernia in (b)(6) 2022.As reported, the subject patient will undergo scan on (b)(6) 2022.As reported, the reported adverse event (abdomen bulge/hernia) has been assessed per clinician as definitely related to the study device and definitely related to the procedure and recovering/resolving.The ae has been assessed as mild in severity.The reported ae does not meet the definition of a sae (serious adverse event) or uade (unanticipated adverse device event).

• 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: 15478144
• Report Number: 1213643-2022-00629
• Device Sequence Number: 20334957
• Product Code: OOD
• UDI-Device Identifier: 00801741107580
• UDI-Public: (01)00801741107580
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 12/21/2022

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: 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): Follow-Up
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 12/16/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 01/03/2023
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 116 KG