MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-07-23 for STRETCH VINYL EXAM GLOVE FG1501 manufactured by Medline Industries, Inc..
[20108341]
The end user developed a rash after wearing the gloves and was treated with prednisone.
Patient Sequence No: 1, Text Type: D, B5
[20385888]
While wearing the gloves, a dietary employee experienced itching of her hands which then spread to other areas of her body. Prednisone was prescribed. The gloves had recently been introduced into this department. It is not known if there may have been other contributing factors in the department that may have caused this irritation. Due to the need for medical intervention and in an abundance of caution, this medwatch is being filed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00073 |
| MDR Report Key | 3981184 |
| Report Source | 05,06 |
| Date Received | 2014-07-23 |
| Date of Report | 2014-07-22 |
| Date of Event | 2014-06-13 |
| Date Mfgr Received | 2014-06-24 |
| Device Manufacturer Date | 2014-01-01 |
| Date Added to Maude | 2014-08-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRETCH VINYL EXAM GLOVE |
| Product Code | LYZ |
| Date Received | 2014-07-23 |
| Catalog Number | FG1501 |
| Lot Number | JJ406907512 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-07-23 |