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 Foreign Body Reaction (1868); Inflammation (1932); Swelling/ Edema (4577)

Event Date 11/08/2021

Event Type  Injury  

Event Description

It was reported that a patient underwent an unknown procedure on (b)(6) 2021 and the mesh was implanted.It was reported that there was post-op inflammation.It was reported that when changing the dressing two days after surgery, the incision was found to be red and swollen.Considering the rejection reaction, it improved after strengthening with systemic and local treatment.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).The provided lot number, okbbwwbo, is an invalid lot 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: weight, bmi at the time of index procedure.Name of initial surgical procedure.The diagnosis and indication for the initial surgical procedure? other relevant patient history/concomitant medications.Product lot #? okbbwwbo ( is not a valid lot number in our system?) does the patient have known allergic history to medical device, food or medications? was there any allergy testing performed? if yes, results? does the surgeon believe there was any deficiency with the ethicon product involved? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status?.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 01/22/2022.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 b5 narrative: it was reported that a patient underwent a hernia repair on (b)(6) 2021 and the mesh was implanted.It was reported that there was post-op inflammation.It was reported that when changing the dressing two days after surgery, the incision was found to be red and swollen.Considering the rejection reaction, it improved after strengthening with systemic and local treatment.Additional information was requested.Additional information was requested and the following was obtained: the patient demographic info: weight, bmi at the time of index procedure male and 69 years old.Name of initial surgical procedure: unknown.The diagnosis and indication for the initial surgical procedure? inguinal hernia.Other relevant patient history/concomitant medications unk.Product lot #? okbbwwbo ( is not a valid lot number in our system?) unk.Does the patient have known allergic history to medical device, food or medications? unk.Was there any allergy testing performed? if yes, results? unk.Does the surgeon believe there was any deficiency with the ethicon product involved? unk.What is physician¿s opinion as to the etiology of or contributing factors to this event? unk.

• 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 D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13062427
• MDR Text Key: 285624336
• Report Number: 2210968-2021-12892
• 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,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2021
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male