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

Catalog Number	1191530
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
As reported per prevent clinical trial (b)(4): as reported, during an open relaparotomy ostomy takedown procedure on (b)(6) 2021, the study patient was implanted with a bard/davol phasix mesh which was trimmed and placed in an onlay fashion.As reported, the patient experienced small bowel obstruction on (b)(6) 2022 unrelated to the device and underwent exploratory laparotomy on the same day.Per the op note, "as we extended our skin incision down through her lower abdominal wound, we encountered some purulent material and encountered the patient's previously placed prophylactic mesh.The mesh was removed in multiple pieces using sharp dissection.The wound did appear grossly contaminated." as reported, the phasix mesh was completely removed a wound vac was placed at the incision site.As reported, the patient was diagnosed with superficial surgical site infection; drainage culture was positive for escherichia coli, the patient was treated with iv and oral antibiotics and was discharged on (b)(6) 2022.As reported, this adverse event is resolving; has been assessed per the study clinician as moderate in severity, possibly related the study device.The ae meets the definition of a serious adverse event (sae) and does not meet the definition of an unidentified adverse device event (uade).
Additional Manufacturer Narrative
As reported, about 4.5 months post-implant of the phasix mesh, during surgery for small bowel obstruction (unrelated to device), surgical site infection was identified, the patient underwent mesh explant and antibiotic treatment.The study clinician has assessed the adverse event to be resolving, "possibly" related the study device and definitely related to the index procedure; however, based on the information provided, no conclusion can be made.Infection is a known inherent risk of surgery and is listed in the adverse reactions section of the instructions-for-use (ifu) supplied with the device as a possible complication.Regarding infection, the warnings section of the 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." review of manufacturing records confirms product was manufactured to specification.This mdr represents the adverse event of surgical site infection.Refer to previously submitted report no.1213643-2021-20462 for information regarding the adverse events of hematoma and small bowel obstruction.Not returned - mesh explanted.

• 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: 14364975
• Report Number: 1213643-2022-00221
• Device Sequence Number: 1982612
• 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
• Device Explanted Year: 2022
• 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): 04/26/2022

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: 12/28/2021
• Device Catalogue Number: 1191530
• Device Lot Number: HUDY1470
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 05/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 75 KG