MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,literature report with the FDA on 2019-04-02 for BONE WAX UNK manufactured by Ethicon Inc..
[140690749]
(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) male) 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? .
Patient Sequence No: 1, Text Type: N, H10
[140690750]
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. A (b)(6) male patient underwent a second revision mastoidectomy for recurrent mastoid cavity infection. Intraoperatively, the sigmoid sinus was inadvertently breached, requiring bone wax (ethicon) for hemostasis. Postoperatively, the patient developed intractable headaches with bilateral papilloedema secondary to increased intracranial pressure in the setting of ipsilateral transverse and sigmoid sinus thromboses, diagnosedon computed tomography. The headaches were mainly situated in the left postauricular and mastoid region and radiated to the left temporal area with associated hyperacusis, pulsatile tinnitus, and intermittent lightheadedness. The patient? S headaches did not respond to analgesia and 6 months of anticoagulation with warfarin. Eight months postoperatively, the patient reported recurrent episodes of extrusion of foreign body from the initial postauricular wound. Exploration of mastoid cavity was done. Histopathology confirmed fibroconnective tissue with a foreign body reaction. Over the next month, the patient? S headaches continued. Due to failed conservative measures and initial immediate symptomatic relief of symptoms with removal of bone wax, we decided to explore his mastoid cavity once again. Again, more bone wax was removed from the sigmoid sinus further distally. Immediately postoperatively, the patient? S headache completely resolved and he returned to his premorbid function. In this case, no response to anticoagulation and analgesia, yet immediate symptomatic relief of the patient? S headache following surgical bone wax removal suggests that sinus venous thrombus occurred secondary to the presence of bone wax. The patient was treated with 5 months of warfarin, with no clinical improvement, suggesting that thrombosis from foreign material could not be lysed but instead required removal. 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 immuno hypersensitivity; for these, alternative hemostatic agents should be considered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2019-79914 |
| MDR Report Key | 8475563 |
| Report Source | FOREIGN,LITERATURE |
| 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 | 3 |
| 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 |