FDA Adverse Event Injury Summary report: N

RESPIRE PINK AT MICRO HARD

MDR report key: 24916798 · Received April 17, 2026

Report

Report Number: 1937100-2026-00002
Event Type: Injury
Date Received: April 17, 2026
Date of Event: March 19, 2026
Report Date: April 17, 2026
Manufacturer: ORTHO SOLUTIONS LC DBA DYNAFLEX
Product Code: LRK
PMA / PMN Number: K192127
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: DENTIST
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

DYNAFLEX EXPLAINED THAT THE METAL ARMS, BALL CLASPS AND METAL HOOKS COULD BE A POSSIBLE CAUSE OF IRRITATION SINCE THE PATIENT HAS A METAL ALLERGY. WE SENT AN ACRYLIC SAMPLE TO THE DOCTORS OFFICE SO THAT THE PATIENT COULD TAKE THE SAMPLE WITH HER TO AN ALLERGIST IF SHE PLANNED ON GETTING TESTING DONE. DYNAFLEX HAS REACHED OUT TO THE DOCTORS OFFICE AND INQUIRED IF THE PATIENT HAD GOTTEN ALLERGY TESTING DONE. WE ARE WAITING FOR A RESPONSE.

Description of Event or Problem · 0

THE DEVICE WAS DELIVERED TO THE PATIENT LAST YEAR AND SHE WORE IT FOR A BIT AND THEN LEFT FOR THE SUMMER AND STOPPED WEARING IT. THEN SHE CAME BACK IN (TO THE DOCTOR'S OFFICE) A FEW WEEKS AGO FOR A CHECK AND THE DOCTOR ENCOURAGED HER TO GO BACK TO WEARING THE APPLIANCE. SHE STATED THAT HER ALLERGY SYMPTOMS CAME BACK RIGHT AWAY AND SHE DIDN'T PUT TWO AND TWO TOGETHER UNTIL NOW. HER SYMPTOMS ARE BURNING TONGUE, CHEEKS, AND LIPS, WITH RED IRRITATION. SHE STATES THAT SHE DOES HAVE A METAL ALLERGY TO EARRINGS AND CAN ONLY WEAR GOLD IN HER EARS BUT THE AREA OF THE ALLERGY SEEMS TO BE MAINLY AROUND THE ACRYLIC.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
977011	RESPIRE PINK AT MICRO HARD	OSA DEVICE	LRK	ORTHO SOLUTIONS LC DBA DYNAFLEX	RESPIRE PINK AT MICRO	R315253

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Required Intervention