MAUDE Adverse Event Report: ETHICON INC. ARTISYN Y-SHAPED MESH; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC

Model Number	ARTY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	01/13/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).  the reported lot, plbcpx0 has been determined to be an invalid lot according to the quality data base.  attempts are being made to obtain the following information.  to date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.The patient demographic info: weight, bmi at the time of index procedure the diagnosis and indication for the initial surgical procedure? what were current symptoms following the index surgical procedure? onset date? what are the patient comorbidities/concomitant medications? were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? were cultures performed? results? was other medical intervention performed? results? product lot #? plbcpx0 is not valid in the quality data base what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? is there an alleged deficiency with the mesh? if so, please explain.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Adverse events related to the patient's first event reported via mw # (b)(4).Adverse events related to the patient's second event reported via mw # (b)(4).
Event or Problem Description
It was reported that a patient underwent a total vaginal hysterectomy and posterior vaginal wall repair and perineoplasty and laparoscopic double adnexectomy and vaginosacral fixation procedure on (b)(6) 2021 and the mesh was implanted.It was reported that there was no anomaly observed during procedure.It was reported that the patient had a post-operation infection and acquired a fever in four days after the procedure.It was reported that the patient was treated with amoxicillin and clavulanate potassium and the patient's condition became stable.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 06/18/2021.Additional information: h6.Additional information was requested and the following was obtained: the patient demographic info: weight, bmi at the time of index procedure.Unknown.The diagnosis and indication for the initial surgical procedure? total vaginal hysterectomy + posterior vaginal wall repair + perineoplasty + laparoscopic double adnexectomy + vaginosacral fixation for the indication of vaginosacral fixation what were current symptoms following the index surgical procedure? onset date?symptoms are fever, pelvic infection, and inability to turn over.Onset date of fever was (b)(6) 2021.What are the patient comorbidities/concomitant medications? unknown.Were there any pre-existing signs/symptoms of active infection prior to this surgical procedure? no.Did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? no.Were cultures performed? results? yes, escherichia coli was found in blood culture.Was other medical intervention performed? results? yes, there was medical treatment, but the effect was not good, and then a second operation was performed, and the effect was good.Product lot #? plbcpx0 is not valid in the quality data base.Unknown.What is physician¿s opinion as to the etiology of or contributing factors to this event?the physician think that it was y-shaped mesh that caused the infection and pain.What is the patient's current status? the patient is in a good condition now.Is there an alleged deficiency with the mesh? if so, please explain.No.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ARTISYN Y-SHAPED MESH
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 11742954
• Report Number: 2210968-2021-03992
• Device Sequence Number: 19913136
• Product Code: OTO
• UDI-Device Identifier: 10705031218475
• UDI-Public: 10705031218475
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113205
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/18/2022

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 Model Number: ARTY
• Device Catalogue Number: ARTY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 05/20/2021; 03/21/2022
• Initial Report FDA Received Date: 04/28/2021
• Supplement Report FDA Received Date: 06/18/2021; 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female