MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-08 for MEDICHOICE manufactured by Owens & Minor Distribution, Inc.
[91359459]
Patient Sequence No: 1, Text Type: N, H10
[91359460]
Indicator on pressure bag does not go up to show the pressure level.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7009411 |
| MDR Report Key | 7009411 |
| Date Received | 2017-11-08 |
| Date of Report | 2017-09-29 |
| Date of Event | 2017-09-20 |
| Report Date | 2017-09-29 |
| Date Reported to FDA | 2017-09-29 |
| Date Reported to Mfgr | 2017-09-29 |
| Date Added to Maude | 2017-11-08 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | MEDICHOICE |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2017-11-08 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWENS & MINOR DISTRIBUTION, INC |
| Manufacturer Address | 6201 GLOBAL DISTRIBUTION WAY SUITE 101 LOUISVILLE KY 40228 US 40228 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-08 |