MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-25 for MEDICATION BAG manufactured by Nxstage Medical, Inc..
[106835656]
White caps of nxstage bags are falling off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5076758 |
| MDR Report Key | 7464219 |
| Date Received | 2018-04-25 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-24 |
| Date Added to Maude | 2018-04-26 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 | MEDICATION BAG |
| Generic Name | SYSTEM, DIALYSATE DELIVERY/ SINGLE PATIENT |
| Product Code | FKP |
| Date Received | 2018-04-25 |
| Lot Number | F1712373 |
| Device Expiration Date | 2019-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NXSTAGE MEDICAL, INC. |
| Manufacturer Address | LAWRENCE MA 01843 US 01843 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-25 |