MAUDE Adverse Event Report: DENT4YOU AG. FLEXI-DAM; DENTAL DAM

Catalog Number	H09946
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Contact Dermatitis (4546)
Date of Event	08/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer stated that they had a patient experience contact dermatitis due to use of the non-latex dam.The reaction was non-serious and was controlled with topical medications without any further medical interventions.The product was being used with single tooth isolation during an endodontic procedure and the dental dam did not tear.The information provided reasonably suggests that the medical device "caused or contributed" to an injury as the patient had to seek medical attention.For this reason, out of an abundance of caution, and per 21 cfr 803, the event is reportable.
Additional Manufacturer Narrative
No product was returned for investigation.The description of the complaint states the patient experienced contact dermatitis due to use of the non-latex dental dam.The dental dam did not tear and the patient was treated with topical medications.H09946 is manufactured as non-latex dental dam and stored in a location sealed and separated from latex dental dam.As the product was not returned, it could not be tested further to determine if the dental dam contained contaminates resulting in skin irritation.

• Brand Name: FLEXI-DAM
• Common Device Name: DENTAL DAM
• Manufacturer (Section D): DENT4YOU AG.; bahnhofstrasse 2; heerbrugg, 9435 ; SZ 9435
• Manufacturer (Section G): COTLENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• Manufacturer Contact: tricia cregger ; 235 ascot parkway; cuyahoga falls, OH 44223
• MDR Report Key: 20263343
• Report Number: 2416455-2024-00004
• Device Sequence Number: 15544749
• Product Code: EIE
• UDI-Device Identifier: 07630392901208
• UDI-Public: (01)07630392901208(10)J181901(11)240207(17)290119
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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: Health Professional
• Device Catalogue Number: H09946
• Device Lot Number: J181901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2024
• 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