MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,literatur report with the FDA on 2017-10-05 for BONE WAX UNK manufactured by Ethicon Inc..
[88385721]
(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. No specific patient information regarding events has 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. Does the surgeon believe that there was any deficiency in the bone wax device? Were these cases previously reported? (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[88385722]
It was reported in a journal article that a patient underwent a laminectomy procedure between may 1 and july 31, 2002 and bone was used. The patient developed a ssis. During procedures in which bone wax was used, it was removed from its foil container and softened by either the scrub nurse or the surgeon by massaging it between gloved fingers. Because the use of the wax occurs late in the procedure when the gloves are more likely to be contaminated with organisms, we hypothesize that the wax might be inoculated at this time. Because several different organisms were isolated from these ssis, it is likely that the source of the contamination was the patient? S own skin flora. The patient received either antibiotic or surgical incision and debridement which was initiated within 3 months of the index surgery. Additional information was requested.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2017-70307 |
| MDR Report Key | 6918895 |
| Report Source | HEALTH PROFESSIONAL,LITERATUR |
| Date Received | 2017-10-05 |
| Date of Report | 2017-08-03 |
| Date Mfgr Received | 2017-09-15 |
| Date Added to Maude | 2017-10-05 |
| 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 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082182792 |
| Manufacturer G1 | ETHICON INC. |
| 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 | 2017-10-05 |
| Catalog Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 088760151 US 088760151 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-10-05 |