Pink Series - H/S SP020USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00851861007079), received between Jun 13, 2018 and Nov 17, 2020 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryNov 17, 2020Inadequacy of Device Shape and/or Size; Inadequacy of Device Shape and/or Size

  A RESPIRE PATIENT WENT TO THE ER FOR INFLAMMATION IN THE GUMS DUE TO THE RETENTION OF DEVICE BEING TOO TIGHT, AND THE DOCTOR HAVING DIFFICULTY REMOVING THE DEVICE FROM THE PATIENT'S MOUTH. THE INFLAMMATION EVENTUALLY WENT AWAY, AND THE PATIENT IS FINE NOW. THIS PATIENT'S DOCTOR SPECIFIES MAXIMUM RETENTION AS THE "PREFERENCES" ON ALL HIS CASES. WHENEVER WE MAKE HIS DEVICES TO THE STANDARD RETENTION, HE STATES THAT THEY ARE TOO LOOSE. MOVING FORWARD WE HAVE TO BE MORE CONSERVATIVE ON THE RETENTION. THE MEDICAL PROFESSIONAL HAS MADE CHAIRSIDE ADJUSTMENTS TO GET IT TO FIT PROPERLY, SINCE RESPIRE PRODUCTS ARE CUSTOM DEVICES THAT THE MEDICAL PROFESSIONAL PARTICIPATES IN DESIGNING. AFTER THE CHAIRSIDE ADJUSTMENTS, THIS DOCTOR DETERMINED THAT THE DEVICE IS SUITABLE FOR THEIR PATIENT TO WEAR.

  Patient problems: Inflammation

  MAUDE report 10853910 ↗
• MalfunctionSep 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A RESPIRE MEDICAL CUSTOMER SERVICE REPRESENTATIVE RECEIVED A CALL FROM A CUSTOMER STATING THAT THEY HAD EXPERIENCED AN ALLERGIC REACTION TO OUR DEVICE.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 7878630 ↗
• MalfunctionJun 13, 2018Break; Break

  A RESPIRE MEDICAL CUSTOMER SERVICE REPRESENTATIVE SPOKE WITH (B)(6), A DOCTOR'S STAFF MEMBER AND WAS TOLD THAT THE PATIENT WOKE UP WITH A BROKEN HINGE IN HIS MOUTH. THERE WAS NO INJURY TO THE PATIENT

  Patient problems: Discomfort

  MAUDE report 7595377 ↗