MAUDE Adverse Event Report: STRYKER MEDICAL STRYKER T-PUMP; MUL-T-PAD

Lot Number 0767C5

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/06/2017

Event Type  malfunction  

Event Description

A postoperative patient had undergone a few gynecological surgeries; a heating pad was applied to her abdomen to relieve discomfort.The pad leaked at the distal end and on observation the product was noted to have a hole in it.No harm or injury occurred to the patient from this issue.

• Brand Name: STRYKER T-PUMP
• Type of Device: MUL-T-PAD
• Manufacturer (Section D): STRYKER MEDICAL
• MDR Report Key: 6650176
• MDR Text Key: 77939106
• Report Number: MW5070482
• Device Sequence Number: 1
• Product Code: ILO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 0767C5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 80