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

Model Number 11450-040

Device Problem Leak/Splash (1354)

Patient Problems Corneal Abrasion (1789); Eye Injury (1845); Chemical Exposure (2570)

Event Date 01/28/2019

Event Type  Injury  

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 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
• Type of Device: 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 drive; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 8695576
• MDR Text Key: 147884615
• Report Number: 1423537-2019-00324
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10630140013751
• UDI-Public: 10630140013751
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other