MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, LARGE, 6X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11443-012B
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device history record reviews were completed on the reported lot v9e175.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One sample was received for investigation on 8/7/19.Site quality engineer had meetings with subject matter experts regarding the sample that was received.The sample had a bubble puncture on the pouch film, which was found to be the root cause for the burst.We are implementing a center-lining project and one-point lesson that would help in ensuring a correct setting of duckbill and brushes.This will help slow down the bubbles when falling into the pouch and prevent the bubble from puncturing the pouch film.We will also continue monitoring our customer complaints data base for this and any other issues reported of the same nature.
Event or Problem Description
Emergency department tech activated the hot pack and it exploded with the contents hitting his face and eye.There is a tear in the corner of the hot pack where the contents came out.No serious injury resulted from this mishap.

• Brand Name: HOT PACK, LARGE, 6X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 8928738
• Report Number: 1423537-2019-00340
• Device Sequence Number: 18961338
• Product Code: IMD
• UDI-Device Identifier: 00888499004880
• UDI-Public: 00888499004880
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V9E175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/24/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention