MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2014-05-19 for VINYL EXAM GLOVE CUR8234 manufactured by Medline Industries, Inc..
[20016673]
The end user developed a rash after wearing the gloves.
Patient Sequence No: 1, Text Type: D, B5
[20304231]
It was reported that the end user developed a rash on her hands after wearing the gloves. She sought medical attention and was prescribed oral steroids. No serious injury resulted. The sample was not returned for evaluation. We have no trend for irritation issues related to use of this glove.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2014-00048 |
| MDR Report Key | 3833423 |
| Report Source | 08 |
| Date Received | 2014-05-19 |
| Date of Report | 2014-05-09 |
| Date of Event | 2014-02-26 |
| Date Mfgr Received | 2014-04-11 |
| Device Manufacturer Date | 2013-08-01 |
| Date Added to Maude | 2014-05-28 |
| 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 | VINYL EXAM GLOVE |
| Product Code | LYZ |
| Date Received | 2014-05-19 |
| Catalog Number | CUR8234 |
| Lot Number | MA306619010 |
| Operator | LAY USER/PATIENT |
| 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 | 2014-05-19 |