MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2005-03-01 for GLV EXAM PF ESTEEM NEU-THERA NITRILE MED * N88RX03T manufactured by Cardinal Health.
[16403824]
Six individuals from housekeeping developed redness and itchy bumps on their hands after wearing the glove. The incidents started in jan. 2005. They went to employee health and the physician there prescribed synalar cream. Also they were instructed to switch to a different glove.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2005-00024 |
| MDR Report Key | 576772 |
| Report Source | 05,07 |
| Date Received | 2005-03-01 |
| Date of Report | 2005-03-01 |
| Date Mfgr Received | 2005-01-31 |
| Date Added to Maude | 2005-03-02 |
| 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 | 0 |
| Manufacturer Contact | MICHELE DONATICH |
| Manufacturer Street | 1430 WAUKEGAN RD BLDG KB |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475786412 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLV EXAM PF ESTEEM NEU-THERA NITRILE MED |
| Generic Name | NITRILE EXAM GLOVE |
| Product Code | LZC |
| Date Received | 2005-03-01 |
| Model Number | * |
| Catalog Number | N88RX03T |
| Lot Number | UNK |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 566614 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | * MCGAW PARK IL * US |
| Baseline Brand Name | GLV EXAM PF ESTEEM NEU-THERA |
| Baseline Generic Name | NITRILE EXAM GLOVE |
| Baseline Model No | N88RX03T |
| Baseline Catalog No | N88RX03T |
| Baseline ID | NA |
| Baseline Device Family | NITRILE EXAM GLOVE |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K032444 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-03-01 |