PEDIATRIC BOBBIN VENT TUBE 500-061Recalls & reported problems
Grace Medical, Inc. · PEDIATRIC BOBBIN VENT TUBE 0.78MM ID BLUE TITANIUM 5 PACK · Class 2 · 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 00844505002547), received between Sep 13, 2021 and Sep 13, 2021 — classified as 1 malfunction.
The most frequently reported specific device problem is “Malposition of Device” (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
- Malposition of Device1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 13, 2021Malposition of Device
DURING THE REVIEW OF THE MAUDE ADVERSE EVENT DATABASE ON AUGUST 19, 2021, IT WAS DISCOVERED THAT A GRACE MEDICAL, INC. PEDIATRIC BOBBIN VENT TUBE WAS REFERENCED IN MDR REPORT NUMBER 1(B)(4) BY A USER FACILITY, AND RECEIVED BY FDA ON 7/30/2021. THE FOLLOWING EVENT WAS REPORTED BY THE USER FACILITY AS FOLLOWS: MODEL NUMBER: 500-061; (B)(4). EVENT DATE: (B)(6) 2021; EVENT TYPE: MALFUNCTION. EVENT DESCRIPTION: "THE TITANIUM TUBE PLACED IN THE LEFT EAR DRUM FOR A BILATERAL MYRINGOTOMY WITH TUBE PLACEMENT FELL FORWARD INTO THE MIDDLE EAR." THE LOT NUMBER REPORTED IS LOT NUMBER 58580.
Patient problems: Insufficient Information
MAUDE report 12463519 ↗
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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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