MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2003-08-28 for SCRUB BRUSH W/12ML PCMX 4456A manufactured by Cardinal Health.
[292694]
Account states that six staff from surgery developed a localized irriation on forearms, wrists and elbows. No new soaps/hand care products or gloves are being used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2003-00111 |
| MDR Report Key | 481196 |
| Report Source | 05,06 |
| Date Received | 2003-08-28 |
| Date of Report | 2003-08-28 |
| Date Mfgr Received | 2003-08-04 |
| Date Added to Maude | 2003-09-04 |
| 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 | 0 |
| Manufacturer Contact | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784148 |
| Manufacturer G1 | CARDINAL HELATH |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85 |
| Manufacturer City | MEXICALLI 21600 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRUB BRUSH W/12ML PCMX |
| Generic Name | SCRUB BRUSH |
| Product Code | GEC |
| Date Received | 2003-08-28 |
| Model Number | 4456A |
| Catalog Number | 4456A |
| Lot Number | Y3C1264 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 470086 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US |
| Baseline Brand Name | SCRUB BRUSH W/12ML PCMX |
| Baseline Generic Name | SCRUB BRUSH |
| Baseline Model No | 4456A |
| Baseline Catalog No | 4456A |
| Baseline ID | NA |
| Baseline Device Family | SCRUB BRUSH |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K854232 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-08-28 |