MAUDE Adverse Event Report: MO016 MO-MOBERLY GEL KIT (2EA), MEDIUM 4.5X10.5IN; PACK, HOT OR COLD, REUSEABLE

Model Number	70304A
Medical Device Problem Code	Excessive Heating (4030)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/24/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Customer reported second degree burn reportedly causing blisters on infant¿s forearm.The product was reportedly heated according to package instructions with the sleeve included.Infant reportedly required three additional days of admission including dressing changes by plastics team before being discharged home.Product discarded.No additional patient demographics provided.
Additional Manufacturer Narrative
We were not able to review the device history report because no sample or lot number were available at the time of the investigation.Not enough information is available from the customer to determine a root cause for the incident reported.Per the instructions, the gel pack is to be used as follows: ¿to microwave: place room temperature gel pack in microwave for 55 seconds at full power (750 watts).Remove pack from microwave with caution.Knead pack to distribute heat evenly.Microwave ovens vary in wattage output.Some may heat at a faster or slower rate.¿ the manufacturing site will continue to monitor this failure mode for this product.
Additional Manufacturer Narrative
The lot number for the product used in this report was not provided, and no physical sample was returned, therefore a device history record review could not be completed.The customer has reported that the product that ¿harmed the patient was unfortunately thrown away¿.The gel formula is mixed to predetermined specifications and mixing data is recorded in the dhr packet.The gel packs are manufactured to predetermined specifications and randomly sampled throughout the production of each lot.Based on asq zero acceptance (c=o), aql=2.5, 35 samples are weighed in process during the production of each lot.If one sample is found out of specification, the product will be rejected and a nonconformance will be created.Based on the information provided, the customer failed to heat the gel pack as instructed.It was reported by the customer that the medium gel pack was heated for 30 seconds in a 1000w microwave.The medium gel pack label instructions states: 'place room temperature gel pack in microwave for 55 seconds at full power (750 watts).' the label also states: 'carefully read all instructions and warnings located on the gel pack before use.Misuse may cause burns or may damage or destroy the product¿.Cardinal health will continue to monitor for similar reports.

• Brand Name: GEL KIT (2EA), MEDIUM 4.5X10.5IN
• Common Device Name: PACK, HOT OR COLD, REUSEABLE
• 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: 13172763
• Report Number: 1423537-2022-00711
• Device Sequence Number: 14574122
• Product Code: IME
• UDI-Device Identifier: 30888499004898
• UDI-Public: 30888499004898
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2022

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: 70304A
• Device Catalogue Number: 70304A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2021
• Supplement Date Received by Manufacturer: 12/10/2021
• Initial Report FDA Received Date: 01/05/2022
• Supplement Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown