MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-08-11 for OAT6801H manufactured by Medline Industries Inc..
[82488064]
An account reported an employee had an allergic reaction to gloves. The employee put the gloves on and after thirty seconds of wearing gloves developed localized itching and rash. The employee removed and discarded the gloved. The employee followed up with a provider and received decadron and anti-histamines to treat the reaction. The reaction improved and the end-user was able to complete the work shift without further incident. A sample was returned and a root cause has not been determined. Due to the reported incident and in an abundance of caution this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
[82488065]
An account reported an employee had an allergic reaction to gloves.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2017-00060 |
| MDR Report Key | 6788186 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-11 |
| Date of Event | 2017-07-24 |
| Date Mfgr Received | 2017-07-24 |
| Device Manufacturer Date | 2017-04-01 |
| Date Added to Maude | 2017-08-11 |
| 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 | MS. MEGAN DEBUS |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | GLOVE, NITRILE |
| Product Code | LYY |
| Date Received | 2017-08-11 |
| Catalog Number | OAT6801H |
| Lot Number | AM709371679 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-11 |