MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-18 for BONE WAX W31G manufactured by Ethicon Inc..
[108722274]
(b)(4). 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. What was the indication for use of the bone wax during cranial vault procedure? How much bone wax was used? Can you describe how much bleeding (in cc)? When did the bleeding occur (during procedure or post op)? If post op, how many days post op initial procedure? What was performed to stop the bleeding? What medical or surgical intervention was indicated? Was any transfusion indicated? Was the patient post op care altered due to the bleeding? What are the patient age, gender, weight, prior medical history? What is the surgeon? S opinion as to the contributing factor to the patient event? What is the current condition of the patient?
Patient Sequence No: 1, Text Type: N, H10
[108722275]
It was reported that a patient underwent cranial vault expansion procedure on unknown date and bone wax was used. The bone wax did not adhere to the skull and did not stop bleeding. The patient experienced excessive bleeding. It is unknown how the procedure was completed. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[110618505]
(b)(4). Additional information was requested and the following was obtained: happened in surgery only one package was used dr. (b)(6) used a hemostatic product to stop the bleeding no adverse effects reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2018-72916 |
| MDR Report Key | 7527384 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-18 |
| Date of Report | 2018-04-28 |
| Date of Event | 2018-04-26 |
| Date Mfgr Received | 2018-06-06 |
| Date Added to Maude | 2018-05-18 |
| 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 KM 154 |
| Manufacturer City | SAO PAOLO 12240 |
| Manufacturer Country | BR |
| Manufacturer Postal Code | 12240 |
| 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 | 2018-05-18 |
| Catalog Number | W31G |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-05-18 |