MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

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

Patient Problems Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Necrosis (1971); Pain (1994); Impaired Healing (2378); Swelling/ Edema (4577)

Event Date 10/20/2020

Event Type  Injury  

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.H6 component code: g07002 ¿ device not returned the single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation:: https://doi.Org/10.1111/clr.13686.

Event Description

Title: soft tissue contour and radiographic evaluation of ridge preservation in early implant placement: a randomized controlled clinical trial the aim of the study is to compare two ridge preservation techniques and spontaneous healing in terms of hard and soft tissue changes 2 months after tooth extraction.The study was designed as a randomized controlled trial and included 75 patients.After single tooth extraction in the maxillary incisor/premolar area, patients were randomly allocated to one of the following groups: (a) ridge preservation with a xenogeneic bone substitute covered with a collagen matrix (cm-group), (b) ridge preservation with a xenogeneic bone substitute covered with a free palatal graft (pggroup) or (c) spontaneous healing (control).In all groups, ethilon (ethicon) sutures were used in the surgery.The harvested graft was placed on top of the dbbm-c and sutured to the marginal gingiva of the socket with 4 to 6 interrupted sutures.The reported complication included (n=2) incomplete healing treatment: not mentioned, (n=1) allergic reaction treatment: not mentioned, (n=1) prolonged bleeding treatment: bipolar electrocoagulation, (n=3) pain and (n=3) swelling.In conclusion, ridge preservation using a xenogeneic bone substitute covered with a collagen matrix or a palatal graft, results in less bone resorption and fewer gbr procedures at early implant placement compared to spontaneous healing.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• 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: 18570163
• MDR Text Key: 333556707
• Report Number: 2210968-2024-00610
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2024
• 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): Required Intervention