MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-03 for CUSTOM GYN URO ROBOT PACK SMA8FGRGMH manufactured by Cardinal.
[104459479]
Custom gyn uro robot pack contained incorrect count of gauze - labeled count 10, contents 11.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076308 |
| MDR Report Key | 7395501 |
| Date Received | 2018-04-03 |
| Date of Report | 2018-04-02 |
| Date of Event | 2018-04-02 |
| Date Added to Maude | 2018-04-04 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 0 |
| Brand Name | CUSTOM GYN URO ROBOT PACK |
| Generic Name | GAUZE |
| Product Code | NAB |
| Date Received | 2018-04-03 |
| Catalog Number | SMA8FGRGMH |
| Lot Number | 853686 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL |
| Manufacturer Address | WAUKEGAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-03 |