MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-11-19 for EMERGENCY RESPONSE PACK, CHEMOTHERAPY DRUG SPILL KIT * manufactured by Tyco Healthcare Group Lp.
[1392317]
Tyco/healthcare kendall chemosafety chemotherapy spill kit contain only 2 chemosorb pads. When the situation arose and there was a spill, 2 chemosorb pads was not adequate to clean the spill. In these situations, another box had to be opened in order to clean the spill. This product should contain more chemosorb pads in order to allow for adequate resources for a chemo spill to be managed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013587 |
| MDR Report Key | 1541749 |
| Date Received | 2009-11-19 |
| Date Added to Maude | 2009-12-03 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EMERGENCY RESPONSE PACK, CHEMOTHERAPY DRUG SPILL KIT |
| Generic Name | CHEMOSORB PADS |
| Product Code | MAC |
| Date Received | 2009-11-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | 904729 |
| ID Number | ITEM # 9618-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TYCO HEALTHCARE GROUP LP |
| Manufacturer Address | * MANSFIELD MA * US * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-11-19 |