FDA Adverse Event
Summary report: N
DEROYAL INDUSTRIES, INC.
MDR report key: 2614426
·
Received June 6, 2012
Report
- Report Number
- 2320762-2012-00005
- Date Received
- June 6, 2012
- Date of Event
- March 12, 2012
- Report Date
- March 12, 2012
- Manufacturer
- UNIMED SURGICAL
- Product Code
- GEI
- PMA / PMN Number
- K962935
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DESCRIBE EVENT: THE HOSPITAL CLAIMS THAT THE INSULATED COATING IS FLAKING OFF OF THE ELECTRODE. DEROYAL: SAMPLES OF THE PRODUCT WERE REQUESTED AND NOT RECEIVED FROM THE CUSTOMER. INVESTIGATION CAN NOT BE PERFORMED WITHOUT THE DEFECTIVE SAMPLE AND ADDITIONAL INFORMATION REGARDING PRODUCT USE.
Description of Event or Problem · 1
THE HOSPITAL CLAIMS THAT THE INSULATED COATING IS FLAKING OFF OF THE ELECTRODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEROYAL INDUSTRIES, INC. | ELECTRODE, BLADE 6" COATED, ENT MODIFIED | GEI | UNIMED SURGICAL | 88-000M11C | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |