MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-08 for EP IMPLANT TRAY ORHS070-12 manufactured by Medical Action Industries, Inc..
[51371684]
Patient Sequence No: 1, Text Type: N, H10
[51371865]
When unfolding the implant tray there was a black "speck" noted inside the basin. No injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5852982 |
| MDR Report Key | 5852982 |
| Date Received | 2016-08-08 |
| Date of Report | 2016-06-20 |
| Date of Event | 2016-05-13 |
| Report Date | 2016-06-20 |
| Date Reported to FDA | 2016-06-20 |
| Date Reported to Mfgr | 2016-06-20 |
| Date Added to Maude | 2016-08-08 |
| 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 | EP IMPLANT TRAY |
| Generic Name | TRAY, SURGICAL, INSTRUMENT |
| Product Code | LRP |
| Date Received | 2016-08-08 |
| Model Number | ORHS070-12 |
| Catalog Number | ORHS070-12 |
| Lot Number | 1061464 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC. |
| Manufacturer Address | 25 HEYWOOD RD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-08-08 |