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 2020-03-25 for DERMABOND ADVANCED 0.7ML - 12EA DNX12 manufactured by Ethicon Inc..
[188518963]
(b)(4). Attempts to obtain the device, however 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. Note: events reported via mw 2210968-2020-02372.
Patient Sequence No: 1, Text Type: N, H10
[188518964]
It was reported a patient underwent an unknown procedure on (b)(6) 2020 and topical skin adhesive was used. The or staff noticed a hair wrapped around the adhesive pen that was open on the sterile tray. Another like kit was used to complete the procedure. There were no patient consequences reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2020-02373 |
| MDR Report Key | 9881559 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-25 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-25 |
| 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 | KARA DITTY-BOVARD |
| Manufacturer Street | P.O. BOX 151, ROUTE 22 WEST |
| Manufacturer City | SOMERVILLE NJ 08876 |
| Manufacturer Country | US |
| Manufacturer Postal | 08876 |
| Manufacturer Phone | 6107428552 |
| Manufacturer G1 | ETHICON INC.-SAN LORENZO PR |
| Manufacturer Street | ROAD 183, KM. 8.3 |
| Manufacturer City | SAN LORENZO 00754 |
| Manufacturer Country | * |
| Manufacturer Postal Code | 00754 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DERMABOND ADVANCED 0.7ML - 12EA |
| Generic Name | ADHESIVE, TOPICAL SKIN |
| Product Code | MPN |
| Date Received | 2020-03-25 |
| Model Number | DNX12 |
| Catalog Number | DNX12 |
| Lot Number | PMH506 |
| Operator | HEALTH PROFESSIONAL |
| 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 08876 US 08876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-25 |