MAUDE Adverse Event Report: STRYKER MEDICAL GAYMAR T-PUMP; PACK, HOT OR COLD, WATER CIRCULATING

Model Number TP500

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Erythema (1840); Swelling (2091)

Event Date 03/27/2015

Event Type  malfunction  

• Brand Name: GAYMAR T-PUMP
• Type of Device: PACK, HOT OR COLD, WATER CIRCULATING
• Manufacturer (Section D): STRYKER MEDICAL; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 4870959
• Report Number: 4870959
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Invalid Data
• Type of Report: Initial
• Report Date: 05/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: TP500
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/26/2015
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 77