MAUDE Adverse Event Report: MO016 MO-MOBERLY INSULATED COLD PACK, M, 6X6.5IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	20204
Health Effect - Clinical Codes	Injury (2348); Disability (2371)
Date of Event	05/04/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At the time of this investigation, no samples or lot numbers were provided to cardinal health.Therefore; without a lot number we were not able to review the device history record and without a sample we were not able to perform any type of investigation in order to determine a root cause for the issue reported.At this time, no corrective actions will be initiated for this complaint.The manufacturing facility will continue to monitor for any similar complaints and take action if determined.
Event or Problem Description
According to the litigation received.Plaintiff claims by reason of the defective product, the plaintiff was caused to sustain severe and permanent personal injuries and disability.
Additional Manufacturer Narrative
On october 3, 2018 cardinal health received pictures of catalog number 20204 as well as the lot number v0k045.The device history record review was completed on the reported lot v0k045.The lot was found to have been manufactured and released to predetermined specifications.No anomalies were found during review of the records.Pictures of the ice pack were evaluated.After review of the pictures, we were unable to determine a root cause, as no anomalies were observed.Without a sample we were not able to perform any type of investigation in order to determine a root cause for the issue reported.At this time, no corrective actions will be initiated for this complaint.The manufacturing facility will continue to monitor for any similar complaints and take action if determined.

• Brand Name: INSULATED COLD PACK, M, 6X6.5IN
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 7855176
• Report Number: 1423537-2018-00237
• Device Sequence Number: 1445124
• Product Code: IMD
• UDI-Device Identifier: 00630140039747
• UDI-Public: 00630140039747
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 20204
• Device Catalogue Number: 20204
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/15/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other