MAUDE Adverse Event Report: PREMIER DENTAL PRODUCTS COMPANY HEMODENT; CORD, RETRACTION

Catalog Number	9007071
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blister (4537)
Date of Event	03/24/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Blistering and swelling were observed on the buccal gingiva following use of hemodent on the cervical area.The symptoms resolved spontaneously within three days.

• Brand Name: HEMODENT
• Common Device Name: CORD, RETRACTION
• Manufacturer (Section D): PREMIER DENTAL PRODUCTS COMPANY; 1710 romano drive; plymouth meeting, PA 19462
• Manufacturer (Section G): MEDICAL PRODUCTS LABORATORIES, INC; 9990 global rd,; philadelphia PA 19115
• Manufacturer Contact: jessica huang ; 1710 romano drive; plymouth meeting, PA 19462 ; 6102396069
• MDR Report Key: 25094726
• Report Number: 2511556-2026-00003
• Device Sequence Number: 5078907
• Product Code: MVL
• UDI-Device Identifier: 00348783001075
• UDI-Public: 00348783001075
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/30/2026

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 Catalogue Number: 9007071
• Device Lot Number: 68482
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 05/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown