MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2018-07-24 for OPTIFLUX F16NRE DIALYZER FINISHED ASSY 0500306E manufactured by Ogden Manufacturing Plant.
[114878461]
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.?
Patient Sequence No: 1, Text Type: N, H10
[114878462]
A nurse at a user facility reported a patient who had an allergic reaction to the fresenius optiflux f16nre dialyzer used during their (b)(6) 2018 treatment. The nurse confirmed that the patient did not complete treatment that day, and was given one-time doses of benadryl and prednisone to relieve the facial and throat swelling. The patient had since resumed their hemodialysis treatments with a different dialyzer without issue, and confirmed the dialyzer used when the patient had their reaction had been discarded. Additional patient information was requested but was not provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713747-2018-00264 |
| MDR Report Key | 7715482 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2018-07-24 |
| Date of Report | 2018-08-21 |
| Date of Event | 2018-07-13 |
| Date Mfgr Received | 2018-08-19 |
| Device Manufacturer Date | 2018-01-31 |
| Date Added to Maude | 2018-07-24 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | THOMAS C. JOHNSON |
| Manufacturer Street | 920 WINTER ST. |
| Manufacturer City | WALTHAM MA 02451 |
| Manufacturer Country | US |
| Manufacturer Postal | 02451 |
| Manufacturer Phone | 7816999499 |
| Manufacturer G1 | OGDEN MANUFACTURING PLANT |
| Manufacturer Street | 475 WEST 13TH STREET |
| Manufacturer City | OGDEN UT 84404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 84404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OPTIFLUX F16NRE DIALYZER FINISHED ASSY |
| Generic Name | DIALYZER, CAPILLARY, HOLLOW FIBER |
| Product Code | FJI |
| Date Received | 2018-07-24 |
| Catalog Number | 0500306E |
| Lot Number | 18AU01019 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | MO |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OGDEN MANUFACTURING PLANT |
| Manufacturer Address | 475 WEST 13TH STREET OGDEN UT 84404 US 84404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-07-24 |