MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2003-04-18 for NITRILE EXAM GLOVES, LRG. N8803I manufactured by Cardinal Health.
[17802094]
Dr. States after wearing the glove they experienced skin irritation and itching which required using otc hydrocortisone cream and prescriptive fluocinonlde cream 0. 05%.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00052 |
| MDR Report Key | 454569 |
| Report Source | 04 |
| Date Received | 2003-04-18 |
| Date of Report | 2003-04-18 |
| Date Mfgr Received | 2003-03-21 |
| Date Added to Maude | 2003-04-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN ROAD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | * |
| Manufacturer Street | PLOT 87 KAMPUNG JAWA |
| Manufacturer City | PENANG W. |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITRILE EXAM GLOVES, LRG. |
| Generic Name | EXAM GLOVES |
| Product Code | LZC |
| Date Received | 2003-04-18 |
| Returned To Mfg | 2003-04-11 |
| Model Number | N8803I |
| Catalog Number | N8803I |
| Lot Number | 3H03A533 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 443572 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | NITRILE EXAM GLOVES, LRG |
| Baseline Generic Name | EXAM GLOVES |
| Baseline Model No | N8803I |
| Baseline Catalog No | N8803I |
| Baseline ID | NA |
| Baseline Device Family | GLOVES |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K000813 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-04-18 |