MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-31 for STERILE MINOR PROCEDURE PACK SBA73MNIVD manufactured by Cardinal Health.
[90767967]
During procedure, opened sterile minor procedure pack and found 11 sponges when package indicates only 10.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073054 |
| MDR Report Key | 6990024 |
| Date Received | 2017-10-31 |
| Date of Report | 2017-10-27 |
| Date of Event | 2017-10-27 |
| Date Added to Maude | 2017-10-31 |
| 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 | 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 | STERILE MINOR PROCEDURE PACK |
| Generic Name | TRAY, SURGICAL |
| Product Code | LRP |
| Date Received | 2017-10-31 |
| Catalog Number | SBA73MNIVD |
| Lot Number | 761924 |
| Device Expiration Date | 2019-05-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-10-31 |