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

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

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Not Applicable (3189); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is related to a journal article, therefore no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.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.Was the case ((b)(6) female) discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that ethicon product (bone wax) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon products used in this procedure? reference article: bone wax extrusion through postauricular wounds: a case series.Author(s): samantha m.Baird, mbbs (hons); bing m.Teh, mbbs, phd; kelvin k.M.Lim, mbbs, franzcr; matthew c.Campbell, mbbs, fracs.Citation: laryngoscope, 128:369¿372, 2018 / doi: 10.1002/lary.26697.

Event Description

It was reported in a journal article entitled: bone wax extrusion through postauricular wounds: a case series.Author(s): samantha m.Baird, mbbs (hons); bing m.Teh, mbbs, phd; kelvin k.M.Lim, mbbs, franzcr; matthew c.Campbell, mbbs, fracs.Citation: laryngoscope, 128:369¿372, 2018 / doi: 10.1002/lary.26697.The purpose of this case series is to discuss complications associated with intraoperative bone wax use and discuss alternative hemostatic agents.An (b)(6) woman was diagnosed with carcinoma ex pleomorphic adenoma of the right deep parotid lobe, with direct extension into the temporooccipital base of skull and posterior cranial fossa.Bone wax (ethicon) was used intraoperatively for hemostasis.Five months postoperatively, the patient developed a postauricular ulcer with probable exposed bone.However, ct showed the presence of foreign material with associated mastoid osteomyelitis.The patient¿s mastoid cavity was surgically explored.Histopathology showed ulceration and mixed inflammation, including granulomatous inflammatory reaction and scar in the presence of polarizable foreign material.Tissue culture was positive for pseudomonas aeruginosa and propionibacterium avidum.Repeat ct, mri, and positron emission tomography showed osteomyelitis, radionecrosis, and tumor regression.The patient was treated with a prolonged course of intravenous and step-down oral antibiotics with good response.Her wound healed 6 months later.In this case, the combination of radionecrosis and the presence of bone wax likely caused a foreign body infection with poor wound-healing, which led to the development of the postauricular ulcer with bone wax extrusion.Bone wax is a relatively safe hemostatic agent.However, significant complications can occur due to its nonresorbable property, as reported here.Bone wax should be used judiciously, particularly in infected fields and in patients with general immune hypersensitivity; for these, alternative hemostatic agents should be considered.

• Brand Name: BONE WAX
• 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; sao paolo ; BR
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8475545
• MDR Text Key: 140742437
• Report Number: 2210968-2019-79907
• Device Sequence Number: 1
• Product Code: MTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR