MAUDE Adverse Event Report: ETHICON INC. SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, STEEL

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

Patient Problem Pain (1994)

Event Date 08/25/2020

Event Type  Injury  

Event Description

Title: orogastric intubation with dental fixation for enteral nutrition: a proof-of-concept study.This randomised crossover clinical trial was designed to test an innovative biomedical technique for enteral nutrition using ogi with dental fixation of the tube access tip.Between july and december 2017, a total of 12 patients among the 13 healthy individuals were included in the study.Most participants were women (n = 10), with a mean (range) age of 32.1 (21 to 65) years, with a mean (range) body mass index (bmi) of 24.5 (18.8 to 30.5) kg/m2.Six participants had facial type i, four had type ii, and two had facial type iii.Half of the participants (n = 6) started the trial using ngi and ogi was performed in the other six participants.In the ogi technique, the access tube tip was fixed at the lingual surface of the upper molars using stainless steel wire (size 1.0, johnson & johnson, ethicon).Reported complications include minor gum pain (discomfort) in the region of the tube fixation (n=1), which may need further attention on longer periods of intubation.In conclusion, the new method of orogastric intubation was superior regarding tolerance, comfort, aesthetic appearance, and functional aspects, and was as safe as nasogastric intubation.Orogastric intubation with dental fixation is a promising alternative for enteral nutrition.However, further studies in actual patients are needed before its clinical application.

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.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: british journal of oral and maxillofacial surgery (2021);59:672¿677.

• Brand Name: SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, STEEL
• 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 ; 9083863534
• MDR Report Key: 16094625
• MDR Text Key: 306610980
• Report Number: 2210968-2023-00042
• Device Sequence Number: 1
• Product Code: GAQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/04/2023

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other