MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-08 for PRESOURCE ORTHO PACK SOP56EX20E manufactured by Cardinal Health 200, Llc.
[59387764]
Patient Sequence No: 1, Text Type: N, H10
[59387765]
Operating room staff was opening an upper extremity pack for a case and when the pack was completely opened over the entire back table it was noticed that metal could be seen coming through table cover. Discovered a giant hole near the stickers that keep the packs sealed. It was so big could stick finger through it.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6085890 |
| MDR Report Key | 6085890 |
| Date Received | 2016-11-08 |
| Date of Report | 2016-10-20 |
| Date of Event | 2016-10-06 |
| Report Date | 2016-10-20 |
| Date Reported to FDA | 2016-10-20 |
| Date Reported to Mfgr | 2016-10-20 |
| Date Added to Maude | 2016-11-08 |
| 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 | PRESOURCE ORTHO PACK |
| Generic Name | GENERAL SURGERY TRAY |
| Product Code | LRP |
| Date Received | 2016-11-08 |
| Model Number | SOP56EX20E |
| Catalog Number | SOP56EX20E |
| Lot Number | 541301 |
| ID Number | SOP56EX20E |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 1320 DON HASKINS SUITE A EL PASO TX 79936 US 79936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-08 |