MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2002-03-12 for SCRUB BRUSH SPONGE, SURGICAL 4458A manufactured by Allegiance Healthcare Corp..
[253657]
Two clinicians, one doctor and one nurse, had severe allergic reactions after using the scrub brush. They both got very red and irritated and the doctor developed blisters. The doctor had to take a prescription to alleviate dr's symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2002-00034 |
| MDR Report Key | 380979 |
| Report Source | 06 |
| Date Received | 2002-03-12 |
| Date of Report | 2002-03-12 |
| Date Added to Maude | 2002-03-13 |
| 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 | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRUB BRUSH SPONGE, SURGICAL |
| Generic Name | SCRUB BRUSH |
| Product Code | GEC |
| Date Received | 2002-03-12 |
| Model Number | 4458A |
| Catalog Number | 4458A |
| 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 | 370035 |
| Manufacturer | ALLEGIANCE HEALTHCARE CORP. |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 60085 US |
| Baseline Brand Name | SCRUB BRUSH SPONGE, SURGICAL |
| Baseline Generic Name | SCRUB BRUSH |
| Baseline Model No | 4458A |
| Baseline Catalog No | 4458A |
| Baseline Device Family | PATIENT PREP |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-03-12 |