STEALTH® FIBRA® CLAMP INSERT A0G03Recalls & reported problems
Applied Medical Resources Corporation · CLAMP INSERT · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607915114749), received between Sep 25, 2023 and May 13, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Device Contaminated During Manufacture or Shipping” (2 reports).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Contaminated During Manufacture or Shipping2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 13, 2024Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO#(B)(4). "WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THIS REPORT HAS CER NON-CONFORMANCE ITEMS.". COMPLAINT (B)(4) - A0G03 LOT #1510888 (1 EA.) ¿ PARTICULATE: SUSPECTED HAIR. IMAGE "(B)(6)". TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (INCOMING INSPECTION).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19306303 ↗MalfunctionSep 25, 2023Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping
NAME OF PROCEDURE BEING PERFORMED: NA (INCOMING INSPECTION). DETAILED DESCRIPTION OF EVENT: [DISTRIBUTOR] INCOMING INSPECTION PO#(B)(4). WE WOULD LIKE TO INFORM YOU THAT SOME OF THE PRODUCTS DIDN'T PASS OUR RECEIVING INSPECTION. PLEASE FIND ATTACHED SPREADSHEET. THIS REPORT HAS CER NON-CONFORMANCE ITEMS. - A0G03 LOT #1471847 (B)(4)- PARTICULATE: HAIRLIKE OBJECT IN POUCH "DSCN9411". TYPE OF INTERVENTION: NA (INCOMING INSPECTION). PATIENT STATUS: NA (NO PATIENT INVOLVED).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17813043 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.