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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 Problems Purulent Discharge (1812); Hypersensitivity/Allergic reaction (1907); Pain (1994)
Event Date 12/27/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). To date the device has not been returned. If the device or further details are received at a later date a supplemental medwatch will be sent. 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. If in your possession, may we have a copy of your operative report from the initial procedure to identify what tissue layer the suture was used? can you identify the product code of the vicryl suture that was used? can you identify the product code/ name of nylon suture that was used? do you have any product for evaluation? if so, please provide your address for a shipper kit to return product. Does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? this medwatch report is in response to receipt of maude event report mw5091812 reaction to vicryl captured in mw 2210968-2020-00597.

 
Event Description

It was reported by the patient that they underwent left knee procedure in 2018 and suture was used. The patient experienced a severe allergic reaction , noting pain, constant itching, pus drainage. On approximately (b)(6) 2018, the patient experienced blood leakage, oozing of pus, severe itching, and throbbing pin head sensation around the surgical area. The patient was prescribed an over the counter cream and steroids. The current condition of the patient is unknown. Additional information has been requested.

 
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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 Key9617986
MDR Text Key185907160
Report Number2210968-2020-00598
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER,OTHER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/22/2020
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? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/12/2020
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: 01/22/2020 Patient Sequence Number: 1
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