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U.S. Department of Health and Human Services

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

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ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Not Applicable (3189)
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. 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. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that ethicon products (vicryl and nylon sutures) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products involved? citation: ulus travma acil cerrahi derg 2019;25:172-176; doi: 10. 5505/tjtes. 2018. 18949. - (b)(4).

 
Event Description

It was reported via journal article: "title: penetrating keratoplasty in patients with traumatic corneal scarring. " authors: dilay özek, m. D. , özlem evren kemer, m. D. , mehmet önen, m. D. , emine esra karaca, m. D. Citation: ulus travma acil cerrahi derg 2019;25:172-176; doi: 10. 5505/tjtes. 2018. 18949. This retrospective study aimed to evaluate the results of penetrating keratoplasty (pk) due to trauma-related corneal scarring. Between may 2010 and june 2016, a total of 24 eyes of 24 patients were included in the study. The patients were divided into two groups. In group 1 (n=14 eyes; n=5 females and n=9 males, average age: 39. 15 years, age range: 8- 73 years), the patients had retinal detachment with a corneal scar and hence combined pk, 20-gauge ppv, and intravitreal silicone injection were applied with temporary keratoprosthesis (tkp). Endodiathermy and endolaser were applied where necessary. Group 2 (n=10 eyes; n=2 females and n=8 males, average age: 29. 23 years, age range: 11¿63 years) had only traumatic corneal scarring and thus pk was applied in those patients¿ eyes. Grafts larger than 0. 25 mm were used during pk. The donor cornea was sutured in an interrupted manner using 10/0 nylon sutures (ethicon). In cases where pk was applied with tkp, the cornea was removed with trepanation and then tkp was inserted into the sclera using 6/0 vicryl sutures (ethicon) through six holes on the keratoprosthesis. After application of 20-gauge ppv, the silicone was given, and the full-thickness donor cornea was sutured in an interrupted manner using 10/0 monofilament nylon sutures (ethicon). Postoperative complaints from group 1 included post-keratitis leukoma (n=1), and re-keratoplasty (reason not provided) (n=6). The results presented in this study showed that in cases of eye injuries due to trauma, the eyes subjected to combined vitrectomy and pk had poor visual prognosis and high graft rejection rate compared to those subjected to pk as the only treatment.

 
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Brand NameNYLON SUTURE UNKNOWN PRODUCT
Type of DeviceSUTURE, NONABSORBABLE, SYNTHETIC
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 Key9964821
MDR Text Key189733455
Report Number2210968-2020-03060
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,LITERATURE
Reporter Occupation
Type of Report Initial
Report Date 03/19/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/15/2020
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 Received03/19/2020
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: 04/15/2020 Patient Sequence Number: 1
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