MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-02 for BONE WAX UNK manufactured by Ethicon Inc..
[140742437]
(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.
Patient Sequence No: 1, Text Type: N, H10
[140742438]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-79907 |
| MDR Report Key | 8475545 |
| Date Received | 2019-04-02 |
| Date of Report | 2019-03-06 |
| Date Mfgr Received | 2019-03-06 |
| Date Added to Maude | 2019-04-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DARLENE KYLE |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. BRAZIL |
| Manufacturer Street | RODOVIA PRESIDENTE DUTRA |
| Manufacturer City | SAO PAOLO |
| Manufacturer Country | BR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BONE WAX |
| Generic Name | WAX, BONE |
| Product Code | MTJ |
| Date Received | 2019-04-02 |
| Catalog Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ETHICON INC. |
| Manufacturer Address | P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-02 |