MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC NOVAPLUS; PACK, HOT OR COLD, DISPOSABLE

Model Number V11450-040B

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Patient reported to nursing staff the hot pack leaked onto her skin while she was using it.Patient cleansed the area and no adverse effects were noted or reported.Manufacturer response for hot pack, novplus hot pack.(per site reporter) pending.

• Brand Name: NOVAPLUS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 11862219
• MDR Text Key: 251905965
• Report Number: 11862219
• Device Sequence Number: 1
• Product Code: IMD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/18/2021,05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V11450-040B
• Device Catalogue Number: V11450-040B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/21/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 11315 DA