FDA Adverse Event
Other
Summary report: N
DEROYAL
MDR report key: 2987977
·
Received December 5, 2012
Report
- Report Number
- 3004605321-2012-00018
- Event Type
- Other
- Date Received
- December 5, 2012
- Date of Event
- November 6, 2012
- Report Date
- November 12, 2012
- Manufacturer
- DEROYAL INDUSTRIES, INC.
- Product Code
- KDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVENT OR PROBLEM: THE CLINIC REPORTED THAT WHEN THE MEDICAL ASSISTANT CLOSED THE NEEDLE COUNTER A NEEDLE CAME THROUGH THE FOAM, OUT THE BOTTOM AND STUCK HER IN THE THUMB. DEROYAL: PICTURES OF THE DEFECTIVE PRODUCT HAVE BEEN RECEIVED. THE DEFECTIVE SAMPLE HAS BEEN REQUESTED AND NOT RETURNED AT THIS TIME. INVESTIGATION FOR DETERMINATION OF THE ROOT CAUSE IS STILL IN PROCESS.
Description of Event or Problem · 1
THE CLINIC REPORTED THAT WHEN THE MEDICAL ASSISTANT CLOSED THE NEEDLE COUNTER A NEEDLE CAME THROUGH THE FOAM, OUT THE BOTTOM AND STUCK HER IN THE THUMB.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEROYAL | KDC - INSTRUMENT, SURGICAL, DISPOSABLE | KDD | DEROYAL INDUSTRIES, INC. | 29889739 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |