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

Catalog Number EMW810T

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

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932)

Event Date 03/12/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).A manufacturing record evaluation was performed for the finished device lot number am5937, code: emw810t, and no non-conformances / manufacturing irregularities 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.Where in the patient¿s body was the device placed? patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction) what was the onset date from the time of the index surgery? please describe the ¿relevant allergy treatment¿ that was given, i.E., medication name, dose, route (oral, iv, topical, etc), amount of time administered.Other relevant patient history/concomitant medications product code? what is 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 an unknown surgery on an unknown date and bone wax was used.Following the procedure, the patient experienced inflammation and allergy.The patient received relevant allergy treatment.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: 07/24/2020.Additional information was requested, and the following was obtained: reply to the follow-up: unknown, due to after follow-up attempt, no information can be provided from the hospital.The patient demographic info: age, gender, weight, bmi at the time of index procedure date and name of the index surgical procedure.Where in the patient¿s body was the device placed? was the excess bone wax removed from the operative site? patient symptoms- describe the manifestation of reaction (location, severity, appearance, systemic or local reaction).What was the onset date from the time of the index surgery? please describe the ¿relevant allergy treatment¿ that was given, i.E., medication name, dose, route (oral, iv, topical, etc), amount of time administered.Other relevant patient history/concomitant medications product code? what is physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• 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
• MDR Report Key: 10115187
• MDR Text Key: 194311762
• Report Number: 2210968-2020-04327
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EMW810T
• Device Lot Number: AM5937
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR