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	Diarrhea (1811); Rash (2033); Localized Skin Lesion (4542)
Date of Event	06/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As reported, patient had skin lesions and rash post implant of phasix st mesh.Based on the available information, no conclusion can be made.The information provided does not indicate a cause for the patient¿s postoperative course.However, as reported this is a patient with a history prior to phasix st mesh implant, of post surgical skin rash and lesions.The adverse reactions section of the instructions-for-use, supplied with the device lists allergic reaction as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant ((b)(6) 2023) is provided as an estimate based.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
As reported, about 2 weeks post implant of a phasix st mesh used in a robotic ventral hernia repair as intraperitoneal onlay, the patient presented with an abdominal rash and skin lesions.As reported, the surgeon did not treat the patient; however, the patient had been applying over the counter rash cream and reported some improvement.As reported, the surgeon will be following up on patient in another month, at this time decided to continue to monitor the patient with no additional treatment.Surgeon also states the patient reports having diarrhea, but is unsure of mesh connection.Note, prior to mesh implant the patient has a history of post surgical skin rash and lesions.
Additional Manufacturer Narrative
As reported, patient had skin lesions and rash post implant of phasix st mesh.Based on the available information, no conclusion can be made.The information provided does not indicate a cause for the patient¿s postoperative course.However, as reported this is a patient with a history prior to phasix st mesh implant, of post surgical skin rash and lesions.The adverse reactions section of the instructions-for-use, supplied with the device lists allergic reaction as a possible complication.No lot number has been provided; therefore, a review of the manufacturing records is not possible.Note, the date of implant ((b)(6) 2023) is provided as an estimate based.Addendum: this is an addendum to the initial mdr submitted.This supplemental mdr is submitted to document the additional information provided.As reported, about two months post op, patient has been recovered from the skin reactions and doing well.It is unknown at this time, what is causing the patient's condition.However, based on the available information, no conclusion can be made.Updated field: b4, b5 (describe event or problem), e1 (initial reporter phone #), g3, g6, h2, h10 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.
Event or Problem Description
As reported, about 2 weeks post implant of a phasix st mesh used in a robotic ventral hernia repair as intraperitoneal onlay, the patient presented with an abdominal rash and skin lesions.As reported, the surgeon did not treat the patient; however, the patient had been applying over the counter rash cream and reported some improvement.As reported, the surgeon will be following up on patient in another month, at this time decided to continue to monitor the patient with no additional treatment.Surgeon also states the patient reports having diarrhea, but is unsure of mesh connection.Note, prior to mesh implant the patient has a history of post surgical skin rash and lesions.Addendum per additional information: as reported, two months post operatively the patient visited the surgeon.It was reported that the skin reactions have been recovered and the patient is fine.No surgical intervention is needed, the surgeon feels comfortable leaving the mesh implanted.The patient still complains of mild diarrhea, but the surgeon does not believe it¿s related to the mesh.

• 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: 17449656
• Report Number: 1213643-2023-00279
• Device Sequence Number: 7382996
• Product Code: OWT
• UDI-Device Identifier: 00801741095351
• UDI-Public: (01)00801741095351
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K143380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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 Catalogue Number: 1201520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 08/29/2023
• 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 Sex: Male