MalfunctionLHC

MICROTEK THERMABASIN

Received Sep 26, 2019 · Event occurred Sep 11, 2019

Report MW5090075 · MDR key 9128813

Device

Generic name

Warmer, Irigation Solution

Manufacturer

Ecolab / Microtek Medical, Inc.

Product problems

Contamination /Decontamination Problem

Patient

Not reported

No Patient Involvement
No Patient Involvement

Narrative

Description of Event or Problem

THE THERMABASIN WAS FOUND TO HAVE A LONG HAIR INSIDE THE PACKAGING. THE PRODUCT WAS REMOVED FROM THE PLASTIC WRAP. THEN THE OUTER BLUE PAPER WRAP WAS REMOVED AND A LONG HAIR WAS FOUND CLINGING TO THE UNDERSIDE OF THE ACTUAL PLASTIC BASIN. FDA SAFETY REPORT ID# (B)(4).