MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2014-03-06 for CT 5M1546 manufactured by Nipro Corporation *usd*.
[4345285]
It was reported a patient experienced an allergic reaction coincident with hemodialysis (hd) therapy. The patient received hd therapy, with the dialyzer at the hd clinic. It was reported the next day while at home, the patient experienced an allergic reaction of their tongue swelling up. It was reported the patient presented to the hospital and was admitted. The hd nurse reported it was unknown what intervention was performed at the hospital. At the time of this report the patient remained hospitalized; the outcome of the event was not reported. No additional information is available
Patient Sequence No: 1, Text Type: D, B5
[11636741]
(b)(4). (b)(6). As the sample was not returned, a device analysis cannot be completed. The cause was not identified. The manufacturer, nipro performed a batch review and no problem was found on the records, retained samples or production processes. Additionally, nipro performed testing on retained samples and no problem was found. Should additional relevant information become available, a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1416980-2014-07671 |
| MDR Report Key | 3665560 |
| Report Source | 05,07 |
| Date Received | 2014-03-06 |
| Date of Report | 2014-02-07 |
| Date of Event | 2014-01-25 |
| Date Mfgr Received | 2014-02-07 |
| Date Added to Maude | 2014-03-07 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHRISTINA ARNT |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 2242703198 |
| Manufacturer G1 | NIPRO CORPORATION *USD* |
| Manufacturer Street | 8-7 HANUKI-YACHI, NIIDA-AZA |
| Manufacturer City | OHDATE-SHI |
| Manufacturer Country | JA |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2014-03-06 |
| Catalog Number | 5M1546 |
| Lot Number | 13A21DX |
| Device Expiration Date | 2015-12-31 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO CORPORATION *USD* |
| Manufacturer Address | 8-7 HANUKI-YACHI, NIIDA-AZA OHDATE-SHI JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2014-03-06 |