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 2016-12-27 for INTERCEPT DETERGENT ML02-0106 manufactured by Medivators.
[63313158]
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.
Patient Sequence No: 1, Text Type: N, H10
[63313159]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2150060-2016-00053 |
| MDR Report Key | 6205164 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-12-27 |
| Date of Report | 2016-12-27 |
| Date of Event | 2016-11-30 |
| Date Mfgr Received | 2016-11-30 |
| Date Added to Maude | 2016-12-27 |
| 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 | MEGAN DICKEY |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer Phone | 7635533327 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERCEPT DETERGENT |
| Generic Name | DETERGENT FOR ENDOSCOPES |
| Product Code | NVE |
| Date Received | 2016-12-27 |
| Model Number | ML02-0106 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-12-27 |