MAUDE Adverse Event Report: CHURCH & DWIGHT CO., HERO MIGHTY PATCH ORIGINAL; DRESSING, WOUND, OCCLUSIVE

Model Number	MP001
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Event or Problem Description
This spontaneous report (b)(4) from the united states of america was reported by a consumer (age and gender unspecified) who noticed a persistent scar and scab on their face after using the hero mighty patch original.On an unspecified date, the consumer initiated hero mighty patch original topically.After taking them off, the consumer noticed it had left a persistent scab and scar on their face and it was hard to cover with makeup.No additional information was available.The action taken with hero mighty patch original was not applicable.The outcome of the events was not recovered.
Additional Manufacturer Narrative
Not avail.

• Brand Name: HERO MIGHTY PATCH ORIGINAL
• Common Device Name: DRESSING, WOUND, OCCLUSIVE
• Manufacturer (Section D): CHURCH & DWIGHT CO.,; 469 north harrison street; princeton NJ 08543
• Manufacturer (Section G): CHURCH & DWIGHT CO., INC; 500 charles ewing boulevard; NJ
• Manufacturer Contact: jon evison ; church & dwight co., inc; princeton, NJ 08543
• MDR Report Key: 20543685
• Report Number: 2280705-2024-01757
• Device Sequence Number: 7816504
• Product Code: NAD
• UDI-Device Identifier: 00864475000404
• UDI-Public: 00864475000404
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2024

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: MP001
• Device Catalogue Number: NOT AVAIL.
• Device Lot Number: NOT AVAIL.
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown