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

Model Number 11443-012B

Device Problems Burst Container or Vessel (1074); Explosion (4006)

Patient Problems Visual Impairment (2138); Loss of Vision (2139); Burning Sensation (2146); Eye Burn (2523); Device Embedded In Tissue or Plaque (3165); Eye Pain (4467)

Event Date 06/17/2021

Event Type  Injury  

Manufacturer Narrative

The complaint was forwarded to the manufacturing facility where it is currently still under investigation.A follow-up report will be filed once the results have been completed.

Event Description

A hot pack exploded on the staff member while attempting to activate it and the particles went into the staff members eyes.Staff member had to physically remove the clear plastic insert from eyes and face as it had adhered itself to face and eyes, crystal particles had to be washed out of eyes, washed off of face, hair, arms, neck and clothing.Staff member had bilateral eye irritation, burning, and initial loss of sight.Bilateral flush of the eyes with normal saline, eye specialist called in, bilateral eye exam performed according to specialist.Staff member is doing ok now.

Manufacturer Narrative

Supplemental report is being filed since the results of investigation are available.Device history record review could not be completed because a lot number was not provided.No samples were returned for investigation, so the root cause for the burst could not be determined.We will continue to monitor this failure mode for this product.

• 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
• MDR Report Key: 12162788
• MDR Text Key: 261435144
• Report Number: 1423537-2021-00651
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380169267
• UDI-Public: 10885380169267
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Weight: 79