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 Codes	Abdominal Pain (1685); Cellulitis (1768); Sepsis (2067)
Date of Event	04/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, post-implant of the phasix st mesh, the patient was diagnosed with abdominal wall cellulitis and sepsis, underwent i&d and treated with iv antibiotics.As reported, the aes are resolved.The clinician has assessed the patient¿s postoperative course of abdominal wall cellulitis as being "possibly" related to the study device and definitely related to the procedure and the sepsis as "possibly" related to the study device and possibly related to the procedure, however, based on the information provided, no conclusion can be made.Review of manufacturing records shows product was manufactured to specification.Infection and pain are known inherent risks of hernia repair surgery.The adverse reactions section of the instructions-for-use (ifu), supplied with the device lists infection and pain as possible complications.In regards to the 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 mesh." this mdr reports the adverse event of abdominal wall cellulitis and sepsis.An additional mdr has been submitted to report the additional adverse event of abdominal wall abscess.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
Reported per clinical trial dvl-he-020: on (b)(6) 2018, subject patient underwent a robotic-assisted multiple recurrent midline ventral hernia (12 cm x 13 cm) repair procedure.Swiss cheese configuration noted.A bard/davol phasix st mesh was placed midline in an underlay fashion and fixated using sutures.Complete fascia closure could not be achieved due to poor quality fascia and full skin closure was achieved using adhesive skin closure and the subject patient was discharged to home on (b)(6) 2018.On (b)(6) 2018, subject patient presented with worsening abdominal pain and tenderness at the ileo conduit ureterostomy site.Subject patient was admitted to the hospital and was diagnosed with abdominal wall cellulitis at the site.On (b)(6) 2018, subject patient was diagnosed with sepsis.Subject patient underwent incision and drainage at bed side, urostomy bag replaced to decrease leaking and patient was treated with iv antibiotics.The subject patient was discharged to home on (b)(6) 2018.Per the study clinician, the reported adverse event of abdominal wall cellulitis is assessed to be 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.The reported adverse event of sepsis is assessed as severe, possibly related to the study device and possibly related to the index procedure.The outcome for this ae is reported as recovered/resolved.On (b)(6) 2018, subject patient was diagnosed with abdominal wall abscess and was admitted to the hospital.The patient was treated with iv antibiotics and was discharged on (b)(6) 2018.On (b)(6) 2018, subject patient underwent reoperation for the abdominal wall abscess.Per the study clinician, the reported adverse event (abdominal wall abscess) is 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.

• 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: 14489455
• Report Number: 1213643-2022-00312
• Device Sequence Number: 5186378
• 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: 2018
• 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): 05/17/2022

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: 01/28/2017
• Device Catalogue Number: 1201520
• Device Lot Number: HUAN0319
• 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
• Date Device Manufactured: 02/27/2016
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 85 KG