MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-13 for CUSTOM STERILE PB24HYGMQ manufactured by Cardinal.
[31596310]
Hair discovered when custom sterile procedure tray opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5057941 |
| MDR Report Key | 5235238 |
| Date Received | 2015-11-13 |
| Date of Report | 2015-11-13 |
| Date of Event | 2015-11-13 |
| Date Added to Maude | 2015-11-19 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CUSTOM STERILE |
| Generic Name | KIT, ABDOMINAL HYSTERECTOMY |
| Product Code | LRP |
| Date Received | 2015-11-13 |
| Catalog Number | PB24HYGMQ |
| Lot Number | 381757 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL |
| Manufacturer Address | US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-13 |