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	Abdominal Pain (1685); Seroma (2069)
Date of Event	06/05/2021
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.Seroma and pain are a known inherent risks of abdominal surgery and are listed in the adverse reaction section of the instructions-for-use (ifu) supplied with the device as possible complications.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in october, 2020.Should additional information be provided a supplemental mdr will be submitted.Not returned - remains implanted.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced seroma and abdominal pain post-implant of phasix mesh.On (b)(6) 2021 - the subject patient underwent an open resection of a pelvic mass.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 bard/davol phasix mesh and the midline fascia was completely closed.A 3cm overlap in all directions was achieved.Skin closure was achieved with long-term absorbable suture and surgical glue.On (b)(6) 2021- the subject patient was diagnosed with a postoperative seroma.Patient reports having abdominal pain since index surgery.Pain became severe so went to local ed.As reported, the reported adverse event has been assessed per clinician as definitely related to the study device and definitely related to the procedure.The ae has been assessed as moderate in severity.
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.Seroma and pain are a known inherent risks of abdominal surgery and are listed in the adverse reaction section of the instructions-for-use (ifu) supplied with the device as possible complications.Review of manufacturing records indicate product was manufactured to specification, with no indication of a manufacturing related cause for the event reported.To date, this is the only reported complaint from this manufacturing lot of (b)(4) released for distribution in october, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the additional information regarding the seroma treated through ultrasound guided drainage and recurred again after 10months.The clinician has assessed the patient¿s postoperative course as being ¿definitely¿ related to the study device and to the procedure, however, based on the information provided, no conclusion can be made.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
It was reported to davol that a patient who is part of a clinical study experienced seroma and abdominal pain post-implant of phasix mesh.(b)(6) 2021 - the subject patient underwent an open resection of a pelvic mass.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 bard/davol phasix mesh and the midline fascia was completely closed.A 3cm overlap in all directions was achieved.Skin closure was achieved with long-term absorbable suture and surgical glue.(b)(6) 2021- the subject patient was diagnosed with a postoperative seroma.Patient reports having abdominal pain since index surgery.Pain became severe so went to local ed.As reported, the reported adverse event has been assessed per clinician as definitely related to the study device and definitely related to the procedure.The ae has been assessed as moderate in severity.Addendum per additional information: as reported, the seroma was drained on (b)(6) 2021 via outpatient ultrasound guided drainage.There was no other action taken.It was reported that seroma was previously thought to be resolved but the pet scan showed the seroma has recurred in (b)(6) 2022.As reported, the mri will be repeated on (b)(6) 2022.As reported, the reported adverse event has been assessed per clinician as moderate in severity and definitely related to the study device and definitely related to the 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: 12035007
• Report Number: 1213643-2021-20153
• Device Sequence Number: 19875347
• 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): 08/05/2022

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): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/03/2022
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/19/2022
• 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: Required Intervention
• Patient Age: 47 YR
• Patient Sex: Female
• Patient Weight: 115 KG