MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, SMALL, 4.5X9IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11443-512
Health Effect - Clinical Code	Irritation (1941)
Date of Event	01/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record review was completed on the reported lot v8n239.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.At the time of this investigation one sample was received by the site on 1/24/19.After evaluation it was determined there was a tear found on the bottom of the pouch, likely caused by the conveyor belt on the pack table.All employees involved in this process are being re-trained to create more awareness regarding this failure mode.The pack table is being redesigned to reduce pinch points on the conveyor.We will also continue monitoring our customer complaints database for this and any other issues reported of the same nature.
Event or Problem Description
Based on information received by the customer, reportedly a medical assistant was activating a hot pack when it burst, and the contents landed on her face.The customer reported they immediately washed her face with soap and water, removed her contacts and irrigated her eyes.They reported her eyes were red and irritated.She was seen by two doctors in their practice.During a phone conversation with the customer they reported the medial assistant was doing okay.

• Brand Name: HOT PACK, SMALL, 4.5X9IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 8319976
• Report Number: 1423537-2019-00263
• Device Sequence Number: 1691939
• Product Code: IMD
• UDI-Device Identifier: 50630140015654
• UDI-Public: 50630140015654
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 11443-512
• Device Catalogue Number: 11443-512
• Device Lot Number: V8N239
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/08/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 25 YR