MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-18 for MEDIPAK - STOCKINETTE 6" X 72" * 84-7666 manufactured by Private Labeled Manufactured For Mckesson.
[182718]
Product is a sterile single ply 100% cotton stockinette in a 6" x 72" roll. Pkg 24 roll/case - all of the bags were open at one end. Not sealed and therefore not sterile.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019709 |
| MDR Report Key | 291476 |
| Date Received | 2000-08-18 |
| Date of Report | 2000-08-15 |
| Date of Event | 2000-08-15 |
| Date Added to Maude | 2000-08-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIPAK - STOCKINETTE 6" X 72" |
| Generic Name | STERILE COTTON |
| Product Code | EFN |
| Date Received | 2000-08-18 |
| Model Number | * |
| Catalog Number | 84-7666 |
| Lot Number | 200144 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 282104 |
| Manufacturer | PRIVATE LABELED MANUFACTURED FOR MCKESSON |
| Manufacturer Address | * RICHMOND VA 23228 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-08-18 |