MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Model Number UMS3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930); Inflammation (1932); Skin Inflammation/ Irritation (4545)

Event Date 07/08/2022

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).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.(b)(4).The lot number was reported as rdbdowb0, but is invalid in the quality database.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: age, gender, weight, bmi at the time of index procedure date of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications.Patient symptoms manifestations (location, severity, appearance, systemic or local reaction).Date - time of onset of infection, fever, redness, and inflammation from the surgical procedure? 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? what is the date and surgical findings of the re-operation? was any deficiency or anomaly of the mesh? if yes, please describe it.Product lot #.What is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Event Description

It was reported that a patient underwent a tension free hernia repair of left inguinal hernia on (b)(6) 2022 and the mesh was implanted.It was reported that on the fourth day after surgery, the patient developed continuous high fever, redness around the incision, and the increase of c-reactive protein was obvious, but the infection indicators such as hemogram and procalcitonin were not high.It was reported that considering the rejection of the product, the anti infection was strengthened, and the effect of anti-inflammatory treatment was poor, so the product was taken out in the emergency on the second day after surgery.It was also reported that after taking out the product, the patient's temperature gradually fell to normal.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 08/31/2022 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.Additional information was requested and the following was obtained: the patient demographic info: age, gender, weight, bmi at the time of index procedure: 64 years old, gender: male.Date of initial surgical procedure: (b)(6) 2022.The diagnosis and indication for the initial surgical procedure? the left inguinal area was covered with a reversible mass for 10 years and aggravated for 2 weeks.Other relevant patient history/concomitant medications patient symptoms manifestations (location, severity, appearance, systemic or local reaction): persistent high fever after operation and redness around the incision.Date - time of onset of infection, fever, redness, and inflammation from the surgical procedure?: (b)(6) 2022 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?: yes.Were cultures performed? results? : the c-reactive protein increased obviously, but the blood picture and procalcitonin were not high.What is the date and surgical findings of the re-operation?: (b)(6) 2022 take out the product.Was any deficiency or anomaly of the mesh? if yes, please describe it.Product lot #: no.What is physician¿s opinion as to the etiology of or contributing factors to this event?: after the surgery , there was continuous high fever, the incision was red, and the c-reactive protein was significantly increased.However, the blood picture and procalcitonin and other infection indicators were not high.Considering the rejection of the product, the anti infection was strengthened, and the anti-inflammatory effect was poor.Therefore, the product was taken out in the emergency on (b)(6) 2022.After the product was taken out, the patient's body temperature gradually decreased to normal.What is the patient's current status?: return to normal life.Product complaint # (b)(4).Date sent to the fda: 08/31/2022 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.Correction information: b3.

Manufacturer Narrative

(b)(4) 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 inc, 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.Additional information: d4.Lot number.

Manufacturer Narrative

(b)(4).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 inc, 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.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

• Type of Device: MESH, SURGICAL, POLYMERIC
• 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 22841 ; GM 22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15148685
• MDR Text Key: 297125370
• Report Number: 2210968-2022-06187
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031085947
• UDI-Public: 10705031085947
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/31/2022

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
• Device Operator: Health Professional
• Device Model Number: UMS3
• Device Catalogue Number: UMS3
• Device Lot Number: RDBDQWB0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/11/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 08/22/2022; 12/17/2023; 01/09/2024
• Supplement Dates FDA Received: 08/31/2022; 12/19/2023; 01/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male