MAUDE Adverse Event Report: GAMBRO DIALYSATOREN GMBH TIPSTOP; BANDAGE, LIQUID

Model Number TIPSTOP (114498)

Device Problem Insufficient Information (3190)

Patient Problem Anaphylactic Shock (1703)

Event Date 10/10/2015

Event Type  Injury  

Manufacturer Narrative

-.

Event Description

A patient in (b)(6) was undergoing a dialysis treatment which included a tipstop.Reportedly, the 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.

• Brand Name: TIPSTOP
• Type of Device: BANDAGE, LIQUID
• Manufacturer (Section D): GAMBRO DIALYSATOREN GMBH; holger-crafoord-str. 26; hechingen 72379 ; GM 72379
• Manufacturer Contact: thomas krespach ; holger-crafoord-str. 26; hechingen ; GM
• MDR Report Key: 5612646
• MDR Text Key: 43847253
• Report Number: 9615764-2015-00001
• Device Sequence Number: 1
• Product Code: KMF
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: TIPSTOP (114498)
• Device Catalogue Number: 114498
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 55