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

Model Number 11443-012B

Device Problem Burst Container or Vessel (1074)

Patient Problems Blurred Vision (2137); Eye Pain (4467)

Event Date 12/07/2022

Event Type  malfunction  

Manufacturer Narrative

Device history review was completed on the reported lot v2k274.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One pre-activated sample was received for evaluation and showed a cut in the pouch.The exact root cause could not be determined but was most likely not due to the manufacturing process.The product shipper does indicate ¿do not use a sharp knife¿ when opening the case to avoid any damage to the product.Cardinal health will continue to monitor complaint trends for this reported issue.

Event Description

Team member squeezed bag and it ripped causing forceful discharge of contents.Fluid got into her eyes, causing a burning sensation and blurred vision 48 hours after event with no visible chemical burns noted.The pack material was removed from the team member¿s eyes with a saline eye flush.Team member reported to the emergency department for follow-up.She was referred to ophthalmology and occupational health.Eye drops were prescribed.There was no additional follow up information given.

• 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 rd.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 16113382
• MDR Text Key: 306823537
• Report Number: 1423537-2023-00872
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V2K274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2022
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/29/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female