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

Model Number 11443-012B

Device Problems Break (1069); Burst Container or Vessel (1074); Fluid/Blood Leak (1250)

Patient Problems Erythema (1840); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The complaint sample 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

Customer reported hot pack burst when activating it for a patient.The bag broke and spilt fluid on nurse and patient bed.The nurse washed product off his skin immediately after and reportedly had slight redness; however, no actual injury confirmed.No additional information provided.

Manufacturer Narrative

The original mdr was filed on the wrong product number- v11450-040b.The customer confirmed the correct product number is 11443-012b.Device history record review was completed on the reported lot number v1h103.The lot number was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.We received 1 sample for investigation.We received one sample for investigation.The sample was already activated.The failure could not be confirmed.The manufacturing site will continue to monitor complaint trends.

• 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: 12422388
• MDR Text Key: 271243440
• Report Number: 1423537-2021-00668
• Device Sequence Number: 1
• Product Code: IMD
• UDI-Device Identifier: 10885380167195
• UDI-Public: 10885380167195
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/22/2021

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: V1H103
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2021
• Initial Date Manufacturer Received: 08/08/2021
• Initial Date FDA Received: 09/03/2021
• Supplement Dates Manufacturer Received: 08/08/2021
• Supplement Dates FDA Received: 10/22/2021
• Patient Sequence Number: 1