EXACTAMED H93847Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412476575), received between Mar 20, 2020 and Oct 13, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 13, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF DISPENSING PINS HAD CLEAR RESIDUE ON THE PIN ITSELF. THE RESIDUE WAS FURTHER DESCRIBED "MORE OF AN OIL-BASED CLEAR LUBRICANT COATING THE PRODUCT". THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15595510 ↗
• MalfunctionOct 6, 2022Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF DISPENSING PINS HAD CLEAR RESIDUE ON THE PIN ITSELF. THE RESIDUE WAS FURTHER DESCRIBED "MORE OF AN OIL-BASED CLEAR LUBRICANT COATING THE PRODUCT". THIS ISSUE WAS IDENTIFIED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555282 ↗
• MalfunctionJun 22, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT UN UNSPECIFIED QUANTITY OF DISPENSING PINS WERE CONTAMINATED; FURTHER SPECIFIED THAT THE PACKAGING WAS WET. THIS WAS IDENTIFIED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 10179138 ↗
• MalfunctionMar 20, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE PACKAGING OF AN UNSPECIFIED QUANTITY OF DISPENSING PINS HAD AN OILY EFFECT ON THE PAPER BACKING (PACKAGING). IT WAS FURTHER REPORTED THE PACKAGING ON EACH UNIT WAS PARTIALLY SEE-THROUGH AND DISCOLORED (SIMILAR TO IF OIL HAD CONTACTED THE PAPER). THIS WAS NOTED PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 9862932 ↗