MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L FOAM WRAP, KNEE, UNIV, W/ STRAPS W/4 COLD/HOT PACKS; PACK, HOT OR COLD, DISPOSABLE

Model Number	9387-00
Medical Device Problem Codes	Use of Device Problem (1670); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Rash (2033); Blister (4537)
Date of Event	09/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A complaint was received on 9/25/2023 reporting skin discoloration and blisters occurred with one reported patient.Details were not provided regarding treatment after the rash and blistering occurred.This investigation is ongoing at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
The skin discoloration and blisters occurred with one reported patient.
Additional Manufacturer Narrative
A complaint was received on 9/25/2023 reporting skin discoloration and blisters occurred with one reported patient.Details were not provided regarding treatment after the rash and blistering occurred.The sample was not returned to deroyal for evaluation.Deroyal was unable to determine the true root cause.Due to the root cause finding there were no corrective and or preventive actions taken.Instructions for use are printed on the cold and hot pack.When pack is hot instruction for use states cover or wrap in a towel.Apply to desired area.When the pack is cold, place pack in coldstar cover or wrap in a towel and apply to desired area.Do not lie or sleep on pack.An inventory check of the foam wrap with cold and hot packs was made by deroyal, a total of 8 of 9384-00 were inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: FOAM WRAP, KNEE, UNIV, W/ STRAPS W/4 COLD/HOT PACKS
• Common Device Name: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 17940076
• Report Number: 3004605321-2023-00003
• Device Sequence Number: 12375829
• Product Code: IMD
• UDI-Device Identifier: 00749756101981
• UDI-Public: 00749756101981
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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
• Device Model Number: 9387-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 10/16/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown