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

Catalog Number XCW810T

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Inflammation (1932)

Event Date 03/16/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device product code w810t lot ma7bqlm, and no non-conformances were identified.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.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of the index surgical procedure? the diagnosis and indication for the index surgical procedure? in what location was the bone wax used? what were the current symptoms following the index surgical procedure? onset date? other relevant patient history/concomitant medications if applicable, will the product be returned, return date, tracking information? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status?.

Event Description

It was reported that the patient underwent surgery for fracture of left leg on an unknown date and suture was used.Three days following the procedure, the patient experienced erythema and inflammation on the left leg.Local drainage and anti-inflammatory ceftriaxone sodium were given.Five days' usage of medication let the inflammation disappear.The patient recovered to normal after a week's rehabilitation treatment.Additional information has been requested.

• Brand Name: BONE WAX 2.5GR::
• Type of Device: WAX, BONE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-UK; simpson parkway; kirkton campus; livingston
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 9997048
• MDR Text Key: 188894317
• Report Number: 2210968-2020-03476
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: XCW810T
• Device Lot Number: MA7BQLM
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 32 YR