MAUDE Adverse Event Report: MO016 MO-MOBERLY INFANT TRANSPORT MATTRESS 9.25X19IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	11475-010
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual complaint samples were not returned for investigation and no lot number is available.Therefore, the device history reviews were unable to be completed.Without samples being returned, the root cause cannot be determined.A corrective action could not be taken, as the root cause could not be determined.The manufacturing site will continue to monitor this failure mode for this product.
Event or Problem Description
Medwatch report (b)(4) received ¿stating when popping the mattress to activate the warming agent, the mattress exploded gelatinous chemical material.¿ no demographics provided.

• Brand Name: INFANT TRANSPORT MATTRESS 9.25X19IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 12285179
• Report Number: 1423537-2021-00659
• Device Sequence Number: 17417719
• Product Code: IMD
• UDI-Device Identifier: 00630140017493
• UDI-Public: 00630140017493
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

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
• Operator of Device: No Information
• Device Model Number: 11475-010
• Device Catalogue Number: 11475-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/05/2021
• Patient Sequence Number: 1