MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-03-30 for NITRILE EXAM GLOVE 52003 manufactured by Safeskin Corp..
[15710879]
During a dental visit for a general exam, the pt stated feeling a tingling sensation in mouth within minutes. It progressed to itchiness, swelling, puffiness, and hives. Pt's dentist was wearing the safeskin purple nitrile gloves. The pt contacted general practioner and dentist prescribed cortozine to reduce the swelling. The pt has been tested for a latex allergy previously and is planning on being tested further. Additional info rec'd on 3/1/2000: pt is latex sensitive but has no known chemical allergies. Pt had cap/crown replaced. Pt does not know what chemicals were used by the dentist.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084395-2000-00020 |
| MDR Report Key | 271866 |
| Report Source | 00 |
| Date Received | 2000-03-30 |
| Date of Report | 2000-03-30 |
| Date of Event | 2000-02-24 |
| Date Mfgr Received | 2000-02-28 |
| Date Added to Maude | 2000-04-04 |
| 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 | 3 |
| Manufacturer Contact | ROSEANNA ARENSTORF, SPECIALIST |
| Manufacturer Street | 12671 HIGH BLUFF DR |
| Manufacturer City | SAN DIEGO CA 92130 |
| Manufacturer Country | US |
| Manufacturer Postal | 92130 |
| Manufacturer Phone | 8587948111 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NITRILE EXAM GLOVE |
| Generic Name | POWDER-FREE PT EXAM GLOVE |
| Product Code | LZC |
| Date Received | 2000-03-30 |
| Model Number | NA |
| Catalog Number | 52003 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 263185 |
| Manufacturer | SAFESKIN CORP. |
| Manufacturer Address | 12671 HIGH BLUFF DR. SAN DIEGO CA 92130 US |
| Baseline Brand Name | SAFESKIN NITRILE EXAM |
| Baseline Generic Name | NITRILE EXAM GLOVE |
| Baseline Model No | NA |
| Baseline Catalog No | 52003 |
| Baseline ID | LARGE |
| Baseline Device Family | NON-STERILE NITRILE POWDER-FREE EXAM(SPECIALTY) |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K992162 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-03-30 |