MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS HOT PACK, LARGE, 6X9; PACK, HOT OR COLD, DISPOSABLE

Model Number	V11443-012B
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the rn squeezed a hot pack to activate, the hot pack burst, spilling contents on her pants, shoes, and scrub jacket.There was no contact with skin, no injury or medical treatment required.
Additional Manufacturer Narrative
Device history record review was completed on the reported lot v2c011.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.We received one sample for evaluation.The sample was already activated.The root cause was determined to be torn pouch.The site will continue to monitor complaint trends.A cross-functional team has been established to closely monitor burst complaints; the team is focused on identifying root causes of failure for samples returned to minimize reoccurrence.

• Brand Name: NOVAPLUS HOT PACK, LARGE, 6X9
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer (Section G): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 14161326
• Report Number: 1423537-2022-00748
• Device Sequence Number: 20316472
• Product Code: IMD
• UDI-Device Identifier: 10885380167218
• UDI-Public: 10885380167218
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/20/2022

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
• Operator of Device: Health Professional
• Device Model Number: V11443-012B
• Device Catalogue Number: V11443-012B
• Device Lot Number: V2C011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 04/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG