FDA Adverse Event
Summary report: N
INTERCEPT DETERGENT
MDR report key: 6205164
·
Received December 27, 2016
Report
- Report Number
- 2150060-2016-00053
- Date Received
- December 27, 2016
- Date of Event
- November 30, 2016
- Report Date
- December 27, 2016
- Manufacturer
- MEDIVATORS
- Product Code
- NVE
- UDI-DI
- 00677964043086
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE FACILITY REPORTED THAT A STAFF MEMBER HAD EXPOSURE TO HER EYES FROM INTERCEPT. SHE WAS WEARING GLASSES BUT NOT A PROTECTIVE FACE SHIELD. THE INTERCEPT DETERGENT SPLASHED UP WHEN DOSING THE ENDOSCOPE MANUAL CLEANING SINK. THERE WAS NO REPORTED ADDITIONAL MEDICAL ATTENTION SOUGHT BY THE FACILITY MEMBER. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MEDIVATORS COMPLAINTS SYSTEM.
Description of Event or Problem · 1
THE CASE STATES THAT A STAFF MEMBER AT FACILITY WAS SPLASHED IN THE EYES WITH INTERCEPT DETERGENT. SHE WAS WEARING GLASSES BUT NOT PROTECTIVE FACE SHIELD. THERE IS POTENTIAL FOR CHEMICAL EXPOSURE SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 857480 | INTERCEPT DETERGENT | DETERGENT FOR ENDOSCOPES | NVE | MEDIVATORS | ML02-0106 | 00677964043086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |