InHealth Technologies; Blom-Singer SP 2113Recalls & reported problems
Freudenberg Medical, LLC · Class U · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00848253001784), received between Aug 24, 2017 and Aug 24, 2017 — classified as 1 malfunction.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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
Device problems
- Insufficient Device Problem Information1
Patient problems
- No Code Available1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 24, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
NASAL SEPTAL DEVICE WAS PLACED IN PATIENT SUCCESSFULLY. THE PHYSICIAN DECIDED A DIFFERENT SIZE DEVICE WAS NEEDED AND BEGAN REMOVING THE DEVICE. THE DEVICE WAS REMOVED ONE SIDE AT A TIME. THE LEFT SIDE WAS REMOVED FIRST, SUCCESSFULLY. WHEN THE PHYSICIAN RETURNED TO REMOVE THE RIGHT SIDE, THE DEVICE FELL BACK INTO THE PATIENT'S THROAT AND WAS SUBSEQUENTLY SWALLOWED. THE DEVICE WAS CONFIRMED TO BE IN THE ESOPHAGUS THROUGH X-RAY. THE PHYSICIAN DETERMINED THAT THE DEVICE WILL PASS THROUGH THE PATIENT WITHOUT FURTHER MEDICAL INTERVENTION.
Patient problems: No Code Available
MAUDE report 6817182 ↗
Other Button, Nasal Septal devices
- SUMMIT MEDICAL SP-78105Summit Medical, Inc. · Button, Nasal Septal1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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