MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-04-20 for PRISMAFLEX TPE 107144 manufactured by Gambro Industries.
[43156691]
Unknown.
Patient Sequence No: 1, Text Type: N, H10
[43156692]
A patient in (b)(6) was undergoing his first therapeutic plasma exchange (tpe) secondary to rejection of a renal transplant. Approximately 15 minutes into treatment, the patient experienced sharp back pain. The patient was given perfalgan and the pain decreased gradually and treatment was restarted 25 minutes later.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8010182-2016-00028 |
| MDR Report Key | 5590998 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-04-20 |
| Date of Report | 2016-04-20 |
| Date of Event | 2016-02-23 |
| Date Mfgr Received | 2016-03-21 |
| Device Manufacturer Date | 2016-01-15 |
| Date Added to Maude | 2016-04-20 |
| 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 | THIERRY PALKOVICS |
| Manufacturer Street | 7 AVENUE LIONEL TERRAY |
| Manufacturer City | MEYZIEU |
| Manufacturer Country | FR |
| Manufacturer Phone | 472452525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRISMAFLEX TPE |
| Product Code | MDP |
| Date Received | 2016-04-20 |
| Model Number | 107144 |
| Lot Number | 16A1505 |
| Device Expiration Date | 2019-01-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO INDUSTRIES |
| Manufacturer Address | 7 AVENUE LIONEL TERRAY MEYZIEU 69883 FR 69883 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-20 |