MAUDE Adverse Event Report: DENTSPLY LLC COM-FIT SUPER SENSITIVE EAR LOOP WHITE; MASK, SURGICAL

Catalog Number 0020346FG

Device Problems Device Appears to Trigger Rejection (1524); Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Rash (2033); Swelling (2091)

Event Type  Injury  

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 is available for evaluation, though has not been returned as of this report.Evaluation results will be submitted as they become available.

Event Description

While a hygienist was using a comfit super sensitive ear loop white mask, the hygienist developed a rash, had swelling, and itchy skin around the nose and chin.The medical doctor prescribed an oral steroid topical.

Manufacturer Narrative

Multiple unsuccessful attempts were made to obtain the device for evaluation.A dhr review was conducted with no discrepancies noted.

• Brand Name: COM-FIT SUPER SENSITIVE EAR LOOP WHITE
• Type of Device: MASK, SURGICAL
• Manufacturer (Section D): DENTSPLY LLC; 1301 smile way; york PA 17404
• MDR Report Key: 8502189
• MDR Text Key: 141565907
• Report Number: 2424472-2019-00040
• Device Sequence Number: 1
• Product Code: FXX
• Combination Product (y/n): N
• PMA/PMN Number: K061716
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0020346FG
• Device Lot Number: 18461646
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention