MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-10 for EP PACK ADVH086-05 manufactured by Avid.
[57556870]
When the sterile pack was opened for the procedure, a foreign object was found in the sterile field (clip with three paper disks). The tray was discarded. No harm to pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5065352 |
| MDR Report Key | 6025422 |
| Date Received | 2016-10-10 |
| Date of Report | 2016-10-10 |
| Date of Event | 2016-10-07 |
| Date Added to Maude | 2016-10-13 |
| 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 | EP PACK |
| Generic Name | CUSTOM ANESTHESIA TRAY |
| Product Code | OGD |
| Date Received | 2016-10-10 |
| Model Number | ADVH086-05 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AVID |
| Manufacturer Address | MECHANICSVILLE VA 23116 US 23116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-10 |