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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Inflammation (1932); Blood Loss (2597); No Code Available (3191)
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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. The following information was requested but unavailable: does the surgeon believe that ethicon products (vicryl suture, ethibond suture) involved caused and/or contributed to the post-operative complications of bleeding and inflammation described in the article? does the surgeon believe that ethicon products (mersilene suture, ethilon suture) involved caused and/or contributed to the post-operative complications of bleeding, inflammation, infection and described in the article? does the surgeon believe there was any deficiency with the ethicon products (mersilene suture, ethilon suture. Vicryl suture, ethibond sutures) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics. Citation: the association of coloproctology of great britain and ireland, 21, 588¿594; doi:10. 1111/codi. 14565. Note: events reported via mw 2210968-2020-02138. (b)(4).

 
Event Description

It was reported via journal article: "title: modified gant¿miwa¿thiersch procedure (mucosal plication with anal encircling) for rectal prolapse" authors: y. Iida, k. Honda, h. Saitou, y. Munemoto and h. Tanaka citation: the association of coloproctology of great britain and ireland, 21, 588¿594; doi:10. 1111/codi. 14565. The aim of this study was to evaluate a modified version of gmt (mgmt) in comparison with other procedures. From august 1986 to january 2017, a total of 187 patients (n=21 in mgm group [n=5 male and n=16 female, mean age: 75 years, age range: 52-89 years] and n=166 in mgmt group [n=33 male and n=133 female, mean age: 74 years, age range: 25-96 years]) were included in the study. Patients who had normal anal tone underwent only mgm while patients who had weak anal tone underwent mgmt. During the procedure, the perianal skin was sterilized fully with 10% povidone iodine solution, and a small incision (2¿3 mm) was made at the right side of the perianal skin. A large needle with a thread or tape (which includes ethibond (ethicon), mersiline tape (ethicon), and ethilon no. 2 monofilament nylon thread (ethicon)) was inserted from this incision, introduced subcutaneously, and then the needle was extracted from the left side of the perianal skin. The needle was then reinserted at the same site, again passed subcutaneously, and pulled out of the same incision. In this way, the thread or the tape was placed subcutaneously around the anal canal. A 10-ml syringe (17 mm in diameter) was inserted into the anal canal to ensure suitable tightening of the encirclement when two ends of the thread or the tape were tied together. When a thread was used, it was tied five times. The skin incision was closed with 4-0 vicryl (ethicon). Complaint included rectal bleeding (n=1) which was managed conservatively, perirectal inflammation (n=1), stenosis of the rectum (n=2) breakage or slackening of ethilon threads leading to recurrence (n=6), infection (n=3 out of 10 from mersiline tape, n=10 out of 139 from ethilon). It was reported that out of all patients who developed infection, 13 underwent removal of the threads or tapes, and of these patients, seven had recurrence. In conclusion, mgmt has a number of advantages: it is minimally invasive, technically simple, and is associated with better cosmesis and very low postoperative morbidity and mortality and recurrence.

 
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Brand NameETHILON NYLON SUTURE UNKNOWN PRODUCT
Type of DeviceSUTURE, NONABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9841665
MDR Text Key190126447
Report Number2210968-2020-02139
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
PMA/PMN NumberNA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 02/20/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/17/2020
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/17/2020 Patient Sequence Number: 1
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