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

Model Number	30104
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	06/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) review was completed on the reported lot v9d348.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The hot pack that burst was discarded at the customer¿s location.Ten samples from the same lot were received by the site on 6/19/2019.All samples were already pre-activated.The site quality engineer analyzed the samples, however, the root cause for the burst pack could not be determined.A corrective action will not be initiated at this time as the root cause could not be determined.The site will continue to monitor this complaint mode for this product.
Event or Problem Description
Based on information received from the customer, while sorting through a case of hot packs, one burst onto an employee.She was lightly squeezing them to see if they were hard or usable.She lightly squeezed the package and it burst in her hand and splattered onto her forearm.The employee reportedly received a 1st degree burn to her forearm, that healed a few days later.It was reported that she was originally seen by occupational health, where she was flushed with soap and water.She was then treated at the urgent care center in norfolk.A silvadene dressing was applied by the doctor.

• Brand Name: INSULATED 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: 8732244
• Report Number: 1423537-2019-00327
• Device Sequence Number: 2022475
• Product Code: IMD
• UDI-Device Identifier: 50630140039834
• UDI-Public: 50630140039834
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/25/2019

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: Other
• Device Model Number: 30104
• Device Catalogue Number: 30104
• Device Lot Number: V90346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2019
• Initial Report FDA Received Date: 06/25/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Weight: 71