MAUDE Adverse Event Report: MO016 MO-MOBERLY NOVAPLUS KWIK-KOLD PERI; PACK, HOT OR COLD, DISPOSABLE

Model Number	V11500-010
Health Effect - Clinical Codes	Tissue Damage (2104); Discomfort (2330)
Date of Event	09/05/2019
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.A quality alert is being issued to create more awareness regarding this failure mode.All production employees have been trained on this issue.
Event or Problem Description
Based on information received from the customer the patient reportedly thought the ice pack burst, the patient stated she ran into the shower and rinsed perineal area with water.Nurse lifted perineal pad from ground and found that solution was leaking in a steady stream from tear in pad.Nurse was wearing gloves and noted that the fluid was extremely cold.She immediately assessed patient¿s perineum and noted new blistering on pre-existing hemorrhoids.Blister was small, about 5 mm in diameter.Patient reported relief to baseline after rinsing in the shower; however, remained uncomfortable.Her perineum was already uncomfortable from tissue trauma from recent childbirth, so this is difficult to attribute to the blister alone.

• Brand Name: NOVAPLUS KWIK-KOLD PERI
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): MO016 MO-MOBERLY; 808 w highway 24; moberly MO 65270
• MDR Report Key: 9147879
• Report Number: 1423537-2019-00350
• Device Sequence Number: 418875
• Product Code: IMD
• UDI-Device Identifier: 10630140021831
• UDI-Public: 10630140021831
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: Lay User/Patient
• Device Model Number: V11500-010
• Device Catalogue Number: V11500-010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 10/02/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 36 YR
• Patient Weight: 87