MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-22 for DC921T DRESSING CHANGE KIT * 375182 manufactured by B Braun Medical, Inc..
[540422]
Sterile dressing change kit noted to have hair inside sealed sterile package. This was caught prior to sending to pt and was sequestered in office.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1040148 |
| MDR Report Key | 755952 |
| Date Received | 2006-08-22 |
| Date of Report | 2006-08-22 |
| Date of Event | 2006-08-22 |
| Date Added to Maude | 2006-08-31 |
| 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 | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DC921T DRESSING CHANGE KIT |
| Generic Name | * |
| Product Code | MCY |
| Date Received | 2006-08-22 |
| Model Number | * |
| Catalog Number | 375182 |
| Lot Number | 601078 |
| ID Number | * |
| Device Expiration Date | 2008-08-31 |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 743786 |
| Manufacturer | B BRAUN MEDICAL, INC. |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-08-22 |