MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-17 for STERILE GENERAL PACK SBA40GGNJUA manufactured by Cardinal Health.
[97547651]
Patient Sequence No: 1, Text Type: N, H10
[97547652]
The custom sterile general pack which contains a variety of items, such as towels and mayo covers and other items, was opened to begin surgery when the clinician noticed discoloration inside the pack and some fine pieces of matter which resembled shavings of an unspecified material. Pack was removed and not used.
Patient Sequence No: 1, Text Type: D, B5
[103562591]
Patient Sequence No: 1, Text Type: N, H10
[103562592]
The custom sterile general pack which contains a variety of items, such as towels and mayo covers and other items, was opened to begin surgery when the clinician noticed discoloration inside the pack and some fine pieces of matter which resembled shavings of an unspecified material. Pack was removed and not used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7199087 |
| MDR Report Key | 7199087 |
| Date Received | 2018-01-17 |
| Date of Report | 2017-12-29 |
| Date of Event | 2017-12-28 |
| Report Date | 2017-12-29 |
| Date Reported to FDA | 2017-12-29 |
| Date Reported to Mfgr | 2017-12-29 |
| Date Added to Maude | 2018-01-17 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | STERILE GENERAL PACK |
| Generic Name | GENERAL SURGERY CUSTOM PACK |
| Product Code | KDD |
| Date Received | 2018-01-17 |
| Model Number | SBA40GGNJUA |
| Catalog Number | SBA40GGNJUA |
| Lot Number | 453868 |
| Device Availability | * |
| Device Age | 2 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 7000 CARDINAL PLACE DUBLIN OH 43017 US 43017 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-17 |