MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2004-03-11 for SCRUB BRUSH W/EXIDINE 4458 manufactured by Cardinal Health.
[310623]
Account states that customer indicates the scrub caused, allergic reaction to a nurse, caused a swelling lump. Nurse tried the scrub on two occasions and both times nurse had the same reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423507-2004-00021 |
| MDR Report Key | 515380 |
| Report Source | 05,06 |
| Date Received | 2004-03-11 |
| Date of Report | 2004-03-11 |
| Date Mfgr Received | 2004-02-10 |
| Date Added to Maude | 2004-03-15 |
| 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 | PATRICIA SHARPE-GREGG |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer Phone | 8475784181 |
| Manufacturer G1 | CARDINAL HEALTH |
| Manufacturer Street | 1430 WAUKEGAN RD |
| Manufacturer City | MCGAW PARK IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCRUB BRUSH W/EXIDINE |
| Generic Name | SCRUB BRUSH |
| Product Code | GEC |
| Date Received | 2004-03-11 |
| Model Number | 4458 |
| Catalog Number | 4458 |
| Lot Number | YSL1381 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 504387 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD MCGAW PARK IL 60085 US |
| Baseline Brand Name | SCRUB BRUSH W/EXIDINE |
| Baseline Generic Name | SCRUB BRUSH |
| Baseline Model No | 4458 |
| Baseline Catalog No | 4458 |
| Baseline ID | NA |
| 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. Required No Informationntervention | 2004-03-11 |