MalfunctionGBT

LIBBE

Received Feb 8, 2002

Report MW4003194 · MDR key 378259

Device

Generic name

Rectal Tube

Manufacturer

Tiller Mind Body, Inc

Model number

Catalog number

Lot number

123504

Product problems

Design/structure problem

Patient

Narrative

Description of Event or Problem

REPORTER IS CONCERNED ABOUT THE QUALITY CONTROL OF THE COMPOSITION OF THE PLASTIC USED TO MAKE THE TUBES. THEY STATE THAT AT 102 DEGREES, THE TUBES IN SOME LOTS BECOME SO SOFT THAT THE SPHINCTER MUSCLE IS ABLE TO COLLAPSE THE TUBE.