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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. BONE WAX 2.5GRAMS; WAX, BONE

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ETHICON INC. BONE WAX 2.5GRAMS; WAX, BONE Back to Search Results
Catalog Number W31C
Device Problem Loss of or Failure to Bond (1068)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the following information and the following was obtained: it was reported that this event occurred in multiple procedures, please provide the following information: what is the total number of procedures? as per event description, approx 6-8 case a week where bone wax is used and customer is complaining about the product.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).As per event description it has been logged under another complaint file.What are the procedure name(s) and date(s)? dates not provided, these are used in cardiac procedures.Was there any adverse patient consequence(s) or subsequent medical/surgical intervention? none as of yet.They have refused to continue using w31c, in order to prevent an adverse reaction from occurring.Are these bone wax opened at the beginning of the procedure and left there until they need to use it? or are they opened when it¿s required during the procedure? opened as customer need them.However there are times that we opened as we know we will use for bigger children.Attempts have been made to retrieve the device.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.
 
Event Description
It was reported a patient underwent an unknown cardiac surgery on an unknown date and bone wax was used.The wax is crumbling.No adverse patient consequences reported.
 
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Brand Name
BONE WAX 2.5GRAMS
Type of Device
WAX, BONE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC. BRAZIL
rodovia presidente dutra
km 154
sao paolo 12240 -908
BR   12240-908
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8395486
MDR Text Key137991275
Report Number2210968-2019-79311
Device Sequence Number1
Product Code MTJ
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
PRE-AMEND
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 02/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2023
Device Catalogue NumberW31C
Device Lot NumberAK5709
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/11/2019
Initial Date FDA Received03/06/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2018
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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