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

Catalog Number	1190616
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Abdominal Pain (1685); Abscess (1690); Nausea (1970); Vomiting (2144); Post Operative Wound Infection (2446)
Date of Event	05/31/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device, however, based on the information provided, no conclusion can be made.In regards to infection, the warnings section of the instruction for use (ifu) states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) units released for distribution in april, 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 subcutaneous abscess and surgical site infection post-implant of phasix mesh.On (b)(6) 2021 - the subject patient underwent an open exploratory laparotomy procedure at the umbilical site.A bard/davol phasix mesh was trimmed and placed in onlay fashion.The mesh was fixated using suture.Fascial closure was achieved with non-bard/davol suture, in a continuous running stitch technique.It was reported that prophylactic antibiotic (metronidazole, ceftriaxone) were administered to the patient peri-operatively.On (b)(6) 2021 - the subject patient was diagnosed with a ssi (surgical site infection) of the superficial skin layer and subcutaneous abscess.The patient was admitted to the hospital and started on oral antibiotics.On (b)(6) 2021- the subject patient was discharged home to continue the oral antibiotics.As reported, the reported adverse event of has been assessed per clinician as possibly related to the study device and definitely related to the procedure.The outcome of the adverse event is recovering/resolving and the severity is reported to be moderate.
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device, however, based on the information provided, no conclusion can be made.In regards to infection, the warnings section of the instruction for use (ifu) states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of (b)(4) released for distribution in (b)(6), 2020.This is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the patient's additional adverse event of pain.Postoperative pain is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use as a possible complication.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and procedure, however, based on the information provided, no conclusion can be made.Addendum: h11: this is an addendum previously submitted mdrs to report the additional information.This supplemental mdr is submitted to report the patient's additional adverse event of worsening pain, nausea and vomiting.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and procedure.However, based on the information provided including the patient¿s comorbidity of active crohn¿s disease, 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.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced subcutaneous abscess and surgical site infection post-implant of phasix mesh.(b)(6) 2021 - the subject patient underwent an open exploratory laparotomy procedure at the umbilical site.A bard/davol phasix mesh was trimmed and placed in onlay fashion.The mesh was fixated using suture.Fascial closure was achieved with non-bard/davol suture, in a continuous running stitch technique.It was reported that prophylactic antibiotic (metronidazole, ceftriaxone) were administered to the patient peri-operatively.(b)(6) 2021 - the subject patient was diagnosed with a ssi (surgical site infection) of the superficial skin layer and subcutaneous abscess.The patient was admitted to the hospital and started on oral antibiotics.(b)(6) 2021- the subject patient was discharged home to continue the oral antibiotics.As reported, the reported adverse event of has been assessed per clinician as possibly related to the study device and definitely related to the procedure.The outcome of the adverse event is recovering/resolving and the severity is reported to be moderate.Addendum: (b)(6) 2021 - the subject patient experienced abdominal pain.Addendum per additional information: as reported, the patient¿s experienced adverse event (abdominal pain) has progressed and ongoing since (b)(6) 2021.The patient was treated with medication (lyrica 100mg) daily for the pain.It was reported on (b)(6) 2022, the patient experienced worsening pain, nausea and vomiting.As reported, mild enteritis was identified on a ct, and a colonoscopy was performed and identified active crohn¿s disease.The reported adverse event has been assessed per the clinician as possibly related to the study device and possibly related to the procedure.The outcome of the adverse event is not recovered/not resolved and the severity is reported to be mild.
Event or Problem Description
It was reported to davol that a patient who is part of a clinical study experienced subcutaneous abscess and surgical site infection post-implant of phasix mesh.(b)(6) 2021 - the subject patient underwent an open exploratory laparotomy procedure at the umbilical site.A bard/davol phasix mesh was trimmed and placed in onlay fashion.The mesh was fixated using suture.Fascial closure was achieved with non-bard/davol suture, in a continuous running stitch technique.It was reported that prophylactic antibiotic (metronidazole, ceftriaxone) were administered to the patient peri-operatively.(b)(6) 2021 - the subject patient was diagnosed with a ssi (surgical site infection) of the superficial skin layer and subcutaneous abscess.The patient was admitted to the hospital and started on oral antibiotics.(b)(6) 2021- the subject patient was discharged home to continue the oral antibiotics.As reported, the reported adverse event of has been assessed per clinician as possibly related to the study device and definitely related to the procedure.The outcome of the adverse event is recovering/resolving and the severity is reported to be moderate.Addendum: (b)(6) 2021 - the subject patient experienced abdominal pain.As reported, the reported adverse event of has been assessed per clinician as possibly related to the study device and possibly related to the procedure.The outcome of the adverse event is not recovered/not resolved and the severity is reported to be mild.
Additional Manufacturer Narrative
The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device, however, based on the information provided, no conclusion can be made.In regards to infection, the warnings section of the instruction for use (ifu) states, "if an infection develops, treat the infection aggressively.Consideration should be given regarding the need to remove the mesh.An unresolved infection may require removal of the device." a review of the manufacturing records was performed and found that the lot was manufactured to specification.To date, this is the only reported complaint from this manufacturing lot of 32 units released for distribution in april, 2020.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to report the patient's additional adverse event of pain.Postoperative pain is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use as a possible complication.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and 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.

• 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: 11991621
• Report Number: 1213643-2021-20148
• Device Sequence Number: 845602
• Product Code: OOD
• UDI-Device Identifier: 00801741107528
• UDI-Public: (01)00801741107528
• 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,Followup
• Report Date (Section B): 03/30/2022

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: 01/28/2022
• Device Catalogue Number: 1190616
• Device Lot Number: HUDZ1972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/02/2021
• Supplement Date Received by Manufacturer: 09/20/2021; 03/29/2022
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 09/28/2021; 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 56 KG