MAUDE Adverse Event Report: MO016 MO-MOBERLY HOT PACK, MEDIUM, 6X6.5IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11450-040
Health Effect - Clinical Codes	Corneal Abrasion (1789); Eye Injury (1845); Chemical Exposure (2570)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record was completed on the reported lot v8s254.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.The issue hot pack was discarded at the customer¿s location.We did receive 26 samples from the same lot on 6/6/2019.None of the samples were activated, all were intact.The site quality engineer activated the samples without any issue.Therefore, the root cause for the burst hot pack could not be determined.At this time no corrective action will be taken.We will continue monitoring our customer complaints data base for this and any other issue reported of the same nature.
Event or Problem Description
Based on information received from the customer, the hot pack allegedly sprayed into a registered nurse's eye reportedly causing a scratched cornea as the crystals began to form.The registered nurse was seen in employee health.No further information was provided by the customer due to protected health information (phi).

• Brand Name: HOT PACK, MEDIUM, 6X6.5IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 8695576
• Report Number: 1423537-2019-00324
• Device Sequence Number: 19407980
• Product Code: IMD
• UDI-Device Identifier: 10630140013751
• UDI-Public: 10630140013751
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 06/13/2019

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: 11450-040
• Device Catalogue Number: 11450-040
• Device Lot Number: V8S254
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2019
• Initial Report FDA Received Date: 06/13/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other