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

Catalog Number	1201520
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Unspecified Gastrointestinal Problem (4491)
Date of Event	03/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, two days post-implant of the bard/davol phasix st mesh, the patient was diagnosed with post operative ileus and placed with nasogastric (ng) tubing for decompression.As reported, the ae is resolved.The clinician has assessed the patient¿s postoperative course as being ¿possibly¿ related to the study device and definitely related to the procedure, however, based on the information provided, no conclusion can be made.This mdr reports the ae of post operative ileus.An additional mdr was submitted to report additional ae of hernia recurrence.Not returned.
Event or Problem Description
Reported per clinical trial (b)(4): (b)(6) 2017 - subject patient underwent robotic assisted technique for first time recurrent incisional umbilical hernia repair procedure.The size of hernia defect was 2.1cm x 2.2cm.A bard/davol phasix st mesh was placed in an underlay fashion intra-peritoneally with sutures.Facia and full skin closure was achieved using sutures and adhesive skin closure.(b)(6) 2017 - subject patient diagnosed with post operative ileus with nausea/vomiting and placed with nasogastric (ng) tubing for decompression and the patient diet was advanced slowly.The patient was discharged from the hospital on (b)(6) 2017.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and definitely related to the index procedure.The outcome for this ae is reported as recovered/resolved.(b)(6) 2018 ¿ subject patient underwent physical examination and was diagnosed with a hernia recurrence.(b)(6) 2019 - subject patient underwent recurrent incisional umbilical hernia repair procedure.Reportedly, the mesh was found to disintegrate during the adhesions removal from the anterior abdominal wall.The mesh was removed partially and replaced with a bard/davol ventralight st mesh.Patient was discharged on same day.Per the study clinician, the reported adverse event has been assessed as moderate in severity, possibly related to the study device and possibly related to the index procedure.The outcome for the ae is reported as recovered/resolved.

• Brand Name: PHASIX ST 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: 14488096
• Report Number: 1213643-2022-00300
• Device Sequence Number: 5177170
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 05/16/2022

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: 09/28/2018
• Device Catalogue Number: 1201520
• Device Lot Number: HUAW1953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/28/2022
• Initial Report FDA Received Date: 05/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 104 KG