MAUDE Adverse Event Report: COLTENE WHALEDENT INC. HYGENIC FLEXI DAM NON-LATEX PURPLE; DENTAL DAM (NON-LATEX)

Model Number	H09945
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Urticaria (2278)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
During a dental procedure the product listed and others were used on an adult male.An hour into the procedure the adult male developed itching and hives.Immediately the dentist stopped the procedure and administered a benadryl shot.At this time the adult male is home and in contact with the dentist to figure out what product was used during the procedure.
Additional Manufacturer Narrative
Investigation: the customer states they received one box of non-latex dental dam (h09945), lot unknown (not provided).The customer states that a patient had an allergic reaction to the non-latex dental dam.The product was not returned for analysis.Complaint history analysis shows zero additional complaints of causing allergic reactions in the past year.Testing could not be performed due to the fact that no product was returned.Therefore, the complaint cannot be confirmed.Root cause: 1.Patient sensitivity to a component in the non-latex dental dam.2.Supplier manufacturing issue.3.Patient was allergic/sensitive to another material used during the procedure.Capa not required at this time.This is an isolated and this lot will continue to be monitored for further occurrences.Note: the customer stated on 02/04/2020 that they do not believe the dental dam caused the allergic reaction.They are a latex-free office and have never seen this type of reaction in 25 years.The customer stated that patient was undergoing a root canal procedure and they believe that the sodium hypochlorite or other solution may have caused the reaction.The customer received benadryl from the dentist and the procedure was completed the same day.

• Brand Name: HYGENIC FLEXI DAM NON-LATEX PURPLE
• Common Device Name: DENTAL DAM (NON-LATEX)
• Manufacturer (Section D): COLTENE WHALEDENT INC.; 235 ascot parkway; cuyahoga falls OH 44223
• MDR Report Key: 9521323
• Report Number: 2416455-2019-00004
• Device Sequence Number: 14115598
• Product Code: EIE
• UDI-Device Identifier: D661H099451
• UDI-Public: D661H099451
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: H09945
• Device Catalogue Number: H09945
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 12/26/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Other