MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2015-08-13 for HUMMI manufactured by .
[23114728]
.
Patient Sequence No: 1, Text Type: N, H10
[23114729]
See reported event per medwatch report #(b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009382876-2015-80002 |
| MDR Report Key | 5002148 |
| Report Source | OTHER |
| Date Received | 2015-08-13 |
| Date Mfgr Received | 2015-03-31 |
| Date Added to Maude | 2015-08-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR JORGE HAIDER |
| Manufacturer Street | 20371 LAKE FOREST DR STEA6 |
| Manufacturer City | LAKE FOREST CA 92630 |
| Manufacturer Country | US |
| Manufacturer Postal | 92630 |
| Manufacturer Phone | 7605856525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HUMMI |
| Generic Name | BLOOD DRAW TRANSFER DEVICE |
| Product Code | KST |
| Date Received | 2015-08-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer Address | CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-13 |