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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON-ABSORBABLE
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ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON-ABSORBABLE Back to Search Results
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4).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.Product code? lot#? procedure name? any patient consequences / ae report? was the procedure completed successfully? and how?.
 
Event Description
It was reported that during an unknown procedure on (b)(6) 2017, suture was used.It was reported that the needle detached from the thread without exerting any force.There was a risk of falling into the patient's mouth.There were no patient consequences.Additional information has been requested.
 
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Brand Name
NYLON SUTURE UNKNOWN PRODUCT
Type of Device
SUTURE, NON-ABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville 08876-0151
9082182792
MDR Report Key7178519
MDR Text Key96850781
Report Number2210968-2018-70175
Device Sequence Number1
Product Code GAO
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
K946173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received12/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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