MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-12 for MINOR PACK SUT24ORGMS manufactured by Cardinal.
[75327719]
During opening count, it was found that there was 21 raytec sponges in the minor pack. After two more counts to verify extra sponge, one was removed before the patient entered the room to maintain sponge counts in multiples of 10. "cardinal minor procedure pack" ref "(b)(4)" lot 659231.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069800 |
| MDR Report Key | 6568717 |
| Date Received | 2017-05-12 |
| Date of Report | 2017-05-12 |
| Date of Event | 2017-05-12 |
| Date Added to Maude | 2017-05-16 |
| 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 | 0 |
| Brand Name | MINOR PACK |
| Generic Name | MINOR PACK |
| Product Code | EFQ |
| Date Received | 2017-05-12 |
| Catalog Number | SUT24ORGMS |
| Lot Number | 659231 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-05-12 |