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

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

Patient Problems Wound Dehiscence (1154); Impaired Healing (2378); Post Operative Wound Infection (2446)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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? 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? what surgical or medical intervention has been performed? 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.Related events captured via 2210968-2022-04538, 2210968-2022-04539, 2210968-2022-04540 citation cite: doi: 10.3969/j.Issn.1008-8849.2021.34.013.

Event Description

Title: effect evaluation of pph combined with external hemorrhoidectomy and primary suture assisted with hemorrhoid lotion fumigation in the treatment of mixed hemorrhoids the objective of this study is to investigate the clinical efficacy of stapled hemorrhoidopexy (pph) combined with external hemorrhoidectomy and primary suture assisted hemorrhoid lotion fumigation in the treatment of mixed hemorrhoids.Methods from march 2019 to december 2020, 120 patients with mixed hemorrhoids admitted to the department of anorectal surgery of zhujiang hospital of southern medical university and the department of general surgery of dongfeng people's hospital of zhongshan were selected and divided into 4 groups of 30 patients.Pph (ethicon), 7# silk suture, 2-0 absorbable suture , 3-0 absorbable catgut "8" suture and vicryl 4-0 absorbable suture(ethicon) was used reported complications included had incision dehiscence and delayed wound healing (n=1), incision infection(n=2), wound healing after suture removal in conclusion compared with traditional pph combined with external hemorrhoidectomy and anal incision after open surgery assisted with potassium permanganate solution sitz bath, pph combined with external hemorrhoidectomy and primary suture assisted hemorrhoid lotion fumigation in the treatment of mixed hemorrhoids has the advantages of short postoperative wound healing time, mild pain and edema, and less bleeding.

Manufacturer Narrative

(b)(4).Date sent to the fda: 6/29/2022.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.The following information was requested but unavailable: does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? 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?.

• 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
• MDR Report Key: 14688598
• MDR Text Key: 294908628
• Report Number: 2210968-2022-04540
• 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,Followup
• Report Date: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/16/2022
• 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