MAUDE Adverse Event Report: ETHICON INC. PDS CORD VIO 75CM 1MM; SUTURES - ABSORBABLE

Catalog Number Z812U

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pneumonia (2011); Fluid Discharge (2686)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).Device not returned.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: can you identify the product code and lot number of the products that were used? date/name of initial procedure and date the reaction was first observed.Where was the suture used? in what tissue? was there any alleged deficiency with the suture? what does the reaction look like and how large of an area does the reaction cover? do you have any pictures of the reaction? was there any medical or surgical intervention performed to treat the reaction (product removed; re-operation; re-closure; prescription steroids; antibiotics prescribed; other medication prescribed)? if so, please clarify.Patient¿s current status? will samples from the same lot be returning for evaluation? if yes, to whom should a shipper kit be sent to? please provide name and address.Response: the patient did control exams and the impacted device is not in the cause of the allergy.No further information available.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.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.

Event Description

It was reported that a patient underwent an unknown heart procedure on an unknown date and suture was used in the sternum.Since 3 weeks post-op, the patient presented symptom of allergy.Initially, there was a suspicion of an allergic reaction to the suture placed in the sternum, however, the patient did control exams and the suture was not in the cause of the allergy.Since the procedure on an unknown date, the patient has had pneumonia and has inflammation (crp : c reactive protein at 22).The patient questioned if it was related to the suture.Additional information was requested.

Manufacturer Narrative

(b)(4).Date sent to the fda: 7/18/2022 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 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: h6 health effect clinical and impact codes additional information was requested and the following was obtained: date/name of the initial procedure and date the reaction was first observed.(b)(6) 2022 surgery date.Removal of a benign intracardiac tumor (right ventricle).Where was the suture used? what fabric? pds cord suture used for sternal synthesis (bone tissue) was there a problem with the suture during placement? nope does the patient have an allergic reaction? if so, what does the reaction look like and what is the area covered by this reaction? small disunion with clear discharge, citrine, on the skin scar, size of a pinhead without local inflammation.Favorable evolution with skin closure and drying up of the flow during controls at the end of (b)(6) 2021 and in (b)(6) 2022.Was medical or surgical intervention necessary to treat the reaction (product removed; re-operation; re-closure; prescription steroids; prescribed antibiotics; other prescribed medications)? no no revision surgery.If yes, can you specify? 2 episodes of pneumonia according to the attending physician (documentation?) treated with atb (name?) in (b)(6) and (b)(6) 2022.

• Brand Name: PDS CORD VIO 75CM 1MM
• Type of Device: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14487380
• MDR Text Key: 292488713
• Report Number: 2210968-2022-03997
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N18331
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: Z812U
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2022
• 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