MAUDE Adverse Event Report: DENTSPLY INDUSTRIA E COMERCIO LTDA FORMOCRESOL; CLEANSER, DENTURE, OVER THE COUNTER

Catalog Number 21730050000

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Event Description

In this event it is reported that during use of formocresol the product was spilled on the leg of an employee and the individual experienced skin irritation and went to the emergency department for medical attention.The outcome of this event is unknown as of this mdr.Further information requested.

Manufacturer Narrative

While it is unknown if the device used in this case caused or contributed to the patient¿s symptoms, it is possible as allergic reactions to dental materials are known and reported, with medical consequences being dependent upon the severity of the individual allergic response and subsequent exposure to the same material.Therefore, this event meets the criteria for reportability per 21 cfr part 803.The device was not returned for evaluation and the lot number was not provided for retained-product testing and/or dhr review.

Manufacturer Narrative

Investigation results: investigation other : there is no information about the product batch and without this information it will not be possible to conduct a real investigation.Investigation dhr : the dhr evaluation shows us that: - the material was discontinued in 2015; - the last batch of this material was produced in 2012 and this product contains a shelf life of 3 years.Note: according to the rdc 67/2009 of the brazilian regulatory agency technovigilance, in article 10, 3rd point presents that: " art.10.The adverse events and technical complaints that fall under art.8 of this resolution are exempted from notification when at least one of the following conditions is verified: iii - the only cause of the occurrence of the adverse event or technical complaint was the use of the product after the expiration of the validity or shelf life established by the manufacturer.

• Brand Name: FORMOCRESOL
• Type of Device: CLEANSER, DENTURE, OVER THE COUNTER
• Manufacturer (Section D): DENTSPLY INDUSTRIA E COMERCIO LTDA; rua jose francisco de souza 19; pirassununga sao paulo 13633 -412; BR 13633-412
• Manufacturer (Section G): DENTSPLY INDUSTRIA E COMERCIO LTDA; rua jose francisco de souza 19; pirassununga sao paulo 13633 -412; BR 13633-412
• Manufacturer Contact: hannah seevaratnam ; 221 west philadelphia st.; york, PA 17401 ; 7178457511
• MDR Report Key: 16618858
• MDR Text Key: 312040247
• Report Number: 8040288-2023-00002
• Device Sequence Number: 1
• Product Code: EFT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

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 Catalogue Number: 21730050000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/24/2023
• Initial Date Manufacturer Received: 03/24/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 03/24/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: A
• Patient Sequence Number: 1