MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-17 for RELIZORB manufactured by Alcresta Therapeutics, Inc..
[131210709]
Clinical escalation reviewed for relizorb. Per delivery scheduling assessment on (b)(6) 2018 patients grandfather stated that the patient missed more than 15 doses of the medication. Called and spoke to patients hipaa verified grandfather (b)(6) who stated that the patient missed the doses of medication because she was in the hospital for 3 weeks because her oxygen levels were low and she had a lung infection. He stated that her physicians are aware of her admission. All questions and concerns addressed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5082198 |
| MDR Report Key | 8174928 |
| Date Received | 2018-12-17 |
| Date of Report | 2018-12-14 |
| Date Added to Maude | 2018-12-18 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | RELIZORB |
| Generic Name | ENZYME PACKED CARTRIDGE |
| Product Code | PLQ |
| Date Received | 2018-12-17 |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALCRESTA THERAPEUTICS, INC. |
| Manufacturer Address | ONE NEWTON EXECUTIVE PARK SUITE 100 NEWTON MA 02462 US 02462 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-17 |