FLEXI-DAM
Received Sep 19, 2024 · Event occurred Aug 20, 2024
Report 2416455-2024-00004 · MDR key 20263343
Device
Product problems
- Insufficient Device Problem Information
- Insufficient Device Problem Information
Patient
NA · Unknown
- Contact Dermatitis
- Contact Dermatitis
Narrative
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.
Description of Event or Problem
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.