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

Model Number 11443-012

Device Problem Material Rupture (1546)

Patient Problem Injury (2348)

Event Date 01/01/1980

Event Type  Injury  

Manufacturer Narrative

Device history record reviews were completed on the reported lots v9c314 and v9c381.The lots were 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, no samples were provided to cardinal health.Therefore; without a sample we were not able to perform any type of investigation in order to determine a root cause for the issue reported.Based on analyses conducted, the site has taken several measures and is continuously monitoring the process to help identify failure modes and implement corrective actions.A quality alert has been issued to create more awareness regarding the failure mode.All production employees have been trained on this issue.The site has increased the visual sampling size to ensure defects are being caught prior to being packaged.The manufacturing site has modified the machine parameter sheets and re-trained operators to ensure the brush and duckbill dive position is correct, which slows down the bubble when falling into the pouch and helps prevent bubble punctures on the pouch.

Event Description

Based on the report we received by the customer, the hot pack reportedly burst during activation, and one employee was treated in the emergency department with a saline flush to eyes, face and neck.

• Brand Name: HOT PACK, LARGE, 6X9IN
• 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: 8595040
• MDR Text Key: 144665622
• Report Number: 1423537-2019-00315
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 00888499004880
• UDI-Public: 00888499004880
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11443-012
• Device Catalogue Number: 11443-012
• Device Lot Number: V9C314; V9C381
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other