MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-01-19 for HAND SANITIZER, EPI CLENZ PLUS MSC097028 manufactured by Medline Industries, Inc..
[1016770]
A staff member developed an allergic response after coming in contact with the product. She was evaluated in the er, given oral steroids and discharged.
Patient Sequence No: 1, Text Type: D, B5
[8167830]
A staff member exhibited an allergic response after using the hand sanitizer. She had a rash on her hands. She was evaluated in the emergency room, given oral steroids and released. She had no known allergies. Due to allergic reaction that developed and the subsequent medical intervention, a mdr is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00004 |
| MDR Report Key | 1291845 |
| Report Source | 06 |
| Date Received | 2009-01-19 |
| Date of Report | 2009-01-14 |
| Date Facility Aware | 2008-12-29 |
| Date Added to Maude | 2010-08-03 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HAND SANITIZER, EPI CLENZ PLUS |
| Generic Name | NONE |
| Product Code | KOY |
| Date Received | 2009-01-19 |
| Model Number | MSC097028 |
| Lot Number | 811131 |
| Operator | HEALTH PROFESSIONAL |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-01-19 |