inforMED
MalfunctionMHW

TUBIGRIP

Received Jan 25, 2017 · Event occurred Jan 21, 2017

Report 6275521 · MDR key 6275521

Device

Generic name

Dressing, Compression

Model number

A-433-4

Catalog number

45792

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

51 YR

  • Reaction
  • Reaction

Narrative

Description of Event or Problem

A PATIENT WHO IS ALLERGIC TO LATEX WAS BEING SEEN BY PHYSICAL THERAPY (PT). THE THERAPIST SIZED, FITTED, AND ISSUED A PRODUCT CONTAINING LATEX (TUBIGRIP) TO BE WORN AROUND KNEE. THE THERAPIST WAS UNDER THE IMPRESSION THE PRODUCT WAS LATEX-FREE AT THE TIME OF ISSUE. THERAPIST CONTACT PATIENT IMMEDIATELY AFTER BEING INFORMED BY CLINICAL MANAGER AND INSTRUCTED PATIENT TO STOP USING AND DISCARD IT IMMEDIATELY. PATIENT EXPRESSED UNDERSTANDING AND REPORTED NO ALLERGIC REACTION TO PRODUCT. THE THERAPIST SUGGESTED INTERNAL FIXES TO AVOID THIS FROM HAPPENING: KEEP PRODUCT IN ORIGINAL PACKAGING WHILE STORED. REVIEW PRODUCTS CONTAINING LATEX WITH STAFF. PHYSICALLY SEPARATE LATEX-CONTAINING PRODUCTS FROM REST OF EQUIPMENT.