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

Model Number 11443-012B

Device Problems Explosion (4006); Material Split, Cut or Torn (4008)

Patient Problem Chemical Exposure (2570)

Event Date 07/14/2019

Event Type  malfunction  

Manufacturer Narrative

Device history record reviews were completed on the reported lot v9e175.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.One sample was received for investigation on 8/7/19.Site quality engineer had meetings with subject matter experts regarding the sample that was received.The sample had a bubble puncture on the pouch film, which was found to be the root cause for the burst.We are implementing a center-lining project and one-point lesson that would help in ensuring a correct setting of duckbill and brushes.This will help slow down the bubbles when falling into the pouch and prevent the bubble from puncturing the pouch film.We will also continue monitoring our customer complaints data base for this and any other issues reported of the same nature.

Event Description

Emergency department tech activated the hot pack and it exploded with the contents hitting his face and eye.There is a tear in the corner of the hot pack where the contents came out.No serious injury resulted from this mishap.

• 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: 8928738
• MDR Text Key: 155697879
• Report Number: 1423537-2019-00340
• 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
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11443-012B
• Device Catalogue Number: 11443-012B
• Device Lot Number: V9E175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Date Manufacturer Received: 07/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention