MAUDE Adverse Event Report: MO016 MO-MOBERLY INSULATED REUS GEL PK M 4.5X10.5IN; PACK, HOT OR COLD, DISPOSABLE

Model Number	80304A
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	Blister (4537)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported patient had total abdominal hysterectomy (had block w/ marcaine & exparel pre-op).A heat pack was used post-op for cramping & abdominal pain.Nursing reported heating pack was used per manufacturer guidelines and placed above the binder.A small blistered area noted at incision with surrounding erythema.Patient returned to hospital with concern for burn at incision site and infection.She required admission, plastic surgery consult, and 2 additional procedures with xenograft placement.Patient did report she used heat on her abdomen after discharge- unable to determine type of heating pack used.
Additional Manufacturer Narrative
This 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.
Additional Manufacturer Narrative
As no samples were returned for evaluation, a root cause could not be determined.A review of the device history record could not be performed as a lot was not provided.Cardinal health has made a business decision to close the site which manufactures product 80304a and transition to a third-party manufacturer.Cardinal health will continue to monitor complaint trends for this reported issue.

• Brand Name: INSULATED REUS GEL PK M 4.5X10.5IN
• Common Device Name: 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: 17347427
• Report Number: 1423537-2023-00963
• Device Sequence Number: 5065731
• Product Code: IMD
• UDI-Device Identifier: 00192253061362
• UDI-Public: 00192253061362
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2023

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: Health Professional
• Device Model Number: 80304A
• Device Catalogue Number: 80304A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 06/22/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Female