inforMED
InjuryKOX

REMOVE 8.0 OZ BOTTLE 01

Received Dec 10, 2021 · Event occurred Nov 19, 2021

Report 8043484-2021-02013 · MDR key 12974682

Device

Generic name

Solvent, Adhesive Tape

Catalog number

403300

Lot number

UNK

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Adverse Event Without Identified Device or Use Problem

Patient

Unknown

  • Burn(s)
  • Burn(s)

Narrative

Additional Manufacturer Narrative

H3, H6: THE DEVICE WAS NOT RETURNED FOR EVALUATION, ALL SUPPLIED INFORMATION HAS BEEN REVIEWED AND WE HAVE NOT BEEN ABLE TO CONFIRM THE COMPLAINT. MEDICAL REVIEW CONCLUDE, THE COMPLAINT DETAILS, REPRESENTS A PROCEDURE COMPLICATION AND DOES NOT REPRESENT A DEVICE MALFUNCTION. IT IS UNKNOWN IF THE DIRECTION FOR USE OF THE REMOVE 8.0 OZ BOTTLE 01 WAS ADHERED TO. THE REMOVE IS FLAMMABLE USE IN A WELL-VENTILATED AREA. WASH THE PATIENT¿S SKIN WITH SOAP, WATER AND THEN PAT DRY.¿ ACCORDING TO THE REPORT, THIS EVENT WAS ADDRESSED BY WOUND CARE CONSULT. HOWEVER, SINCE THIS ISSUE WAS UNRESOLVED, THE IMPACT TO THE PATIENT BEYOND THAT WHICH ALREADY BEEN REPORTED IS UNKNOWN. SHOULD ANY ADDITIONAL RELEVANT PATIENT INFORMATION BE PROVIDED, THIS COMPLAINT WOULD BE RE-ASSESSED. A PROBABLE ROOT CAUSE MAY INCLUDED PATIENTS SENSITIVITY TO THE PRODUCT. A DOCUMENTATION REVIEW HAS BEEN CONDUCTED, CONFIRMING NO PREVIOUS COMPLAINTS OF THIS NATURE AND NO HISTORICAL ESCALATIONS HAVE BEEN OBSERVED. A REVIEW OF THE DEVICE HISTORY CONFIRMED THAT NO MANUFACTURING PROBLEMS WHERE OBSERVED. THE INSTRUCTIONS FOR USE CONTAIN COMPREHENSIVE INSTRUCTIONS ON THE SAFE OPERATION AND USE OF THE DEVICE. THE RISK FILES MITIGATE THE REPORTED ISSUE WITH NO UPDATES REQUIRED. THIS INVESTIGATION IS NOW COMPLETE, WITH NO MANUFACTURING PROBLEMS OBSERVED, NO CORRECTIVE ACTIONS ARE DEEMED NECESSARY. SMITH AND NEPHEW CAN CONFIRM THE DEVICE WAS RELEASED ACCORDING TO SPECIFICATIONS AND CONTINUE TO MONITOR FOR ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.

Additional Manufacturer Narrative

INTERNAL COMPLAINT REFERENCE CASE-(B)(4).

Description of Event or Problem

IT WAS REPORTED THAT, DURING WOUND TREATMENT, ONE PATIENT EXPERIENCED BURNS WHEN USING REMOVE 8.0 OZ BOTTLE 01. THIS WAS NOTICED 45 H AFTER APPLICATION. IT IS USED THE ADHESIVE REMOVER, CHLORHEXIDINE, THEN CHLORAPREP, AND THE BURN IS ON THE SIDE OF THE PATIENT WHERE THIS MIGHT HAVE POOLED. THE ADHESIVE REMOVER IS PRIMARILY PLACED ANTERIORLY BUT THE BURNS WHICH LOOK TO BE CHEMICAL BURNS, ARE MORE POSTERIOR/LATERAL. A PAD THAT CIRCULATES HEATED WATER TO HELP WITH BODY TEMPERATURE DURING THE HEART SURGERY IS ALSO LAID. THIS EVENT HAS BEEN ADDRESSED BY WOUND CARE CONSULT. PATIENT IS IN ACUTE CARE FLOOR AND WOUND UPDATE IS NOT KNOWN.