MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2016-04-27 for TIPSTOP manufactured by Gambro Dialysatoren Gmbh.
[43838453]
.
Patient Sequence No: 1, Text Type: N, H10
[43838454]
A patient in (b)(6) was undergoing a dialysis treatment which included a tipstop. Patient had an anaphylactic reaction after hemodialysis. No other patient information is available. The used tipstop was discarded after the event and no further technical investigation can be performed. Patient was not hospitalized.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615764-2015-00003 |
| MDR Report Key | 5613487 |
| Report Source | FOREIGN |
| Date Received | 2016-04-27 |
| Date of Report | 2016-04-27 |
| Date of Event | 2015-10-10 |
| Date Mfgr Received | 2016-03-29 |
| Date Added to Maude | 2016-04-27 |
| 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 KRESPACH |
| Manufacturer Street | HOLGER-CRAFOORD-STR. 26 |
| Manufacturer City | HECHINGEN |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TIPSTOP |
| Generic Name | BANDAGE, LIQUID |
| Product Code | KMF |
| Date Received | 2016-04-27 |
| Model Number | TIPSTOP |
| Lot Number | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GAMBRO DIALYSATOREN GMBH |
| Manufacturer Address | HOLGER-CRAFOORD-STR. 26 HECHINGEN 72379 GM 72379 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-27 |