MAUDE Adverse Event Report: ETHICON INC. SUTURE UNKNOWN; SUTURE, ABSORBABLE

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

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930)

Event Date 03/17/2021

Event Type  Injury  

Event Description

Title: efficacy of palliative resection and ostomy in elderly patients with advanced colon.The objective of this study is to investigate the effect of palliative resection and colostomy in elderly patients with advanced colon cancer.From october 2017 to march 2020, 152 patients with advanced colon cancer who were diagnosed and treated were included in the study.The patients were divided 2 group; 76 patients (39 were males, 37 were females, mean age 65.89 ± 4.44 years) who were treated with instrumental fistulization were included in the fistulization group, and 76 patients (38 males, 38 females, mean age 65.92 ± 5.13) who were treated with palliative resection were included in the palliative group.The patients in the fistulization group were treated with ethicon instrumental fistulization and tubular fistulization devices with caliber 32-34 mm.A non-ethicon suture (manufacturer: unknown) was used for purse-string suture.Patients in the palliative group were treated with palliative resection, including colectomy combined with primary ileal transverse colostomy using unspecified devices.The reported complications included urinary tract infection (n=3), anastomotic bleeding (n=4), pulmonary infection (n=2), abdominal infection (n=2), and incision infection (n=3).In conclusion, compared with gastrostomy, palliative resection in elderly patients with advanced colon cancer can promote short-term rehabilitation, relieve pain, reduce the occurrence of complications and improve the follow-up survival rate.

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.Component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: chinese journal of clinical oncology and rehabilitation, july 2021, vol.28, no.7.

• Brand Name: SUTURE UNKNOWN
• Type of Device: SUTURE, 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 ; 9083863534
• MDR Report Key: 16582445
• MDR Text Key: 311670475
• Report Number: 2210968-2023-01850
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• 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: 03/07/2023
• 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