UNISOLVE 8.0 OZ BTL 01
Received Feb 6, 2019 · Event occurred Jan 9, 2019
Report 8043484-2019-00087 · MDR key 8312934
Device
Generic name
Absorber, Carbon-dioxide
Manufacturer
Smith & Nephew Medical Ltd.Catalog number
59402500
Lot number
57445
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
4 YR
- Burn(s)
- Injury
- Burn(s)
- Injury
Narrative
Additional Manufacturer Narrative
WE HAVE NOW CONCLUDED OUR INVESTIGATION INTO THIS REPORT OF ADVERSE REACTION TO UNISOLVE WHEN THE PRODUCT WAS USED TO REMOVE THE INSULIN PUMP FROM THE UPPER THIGH OF A PATIENT, DURING THE CASE WHERE THE PATIENT MOVED AND THE LIQUID DRIPPED DOWN AND CAUSED A BURN. ADDITIONALLY, WE HAVE INVESTIGATED THE CUSTOMER REQUEST THAT THE MSDS SHOULD BE UPDATED TO SHOW A WARNING THAT THIS COULD BURN SKIN. THE MANUFACTURING INVESTIGATION INCLUDED A DOCUMENTATION REVIEW OF THE MANUFACTURING BATCH RECORD OF THE PRODUCT LOT, REVIEW OF PRODUCT HISTORY, AND VISUAL INSPECTION OF THE RETURNED SAMPLE. NO ANOMALIES OCCURRED DURING THE MANUFACTURE OF THIS PRODUCT LOT. VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THAT THE PRODUCT IS PROPERLY LABELED UNISOLVE AND NO FALSIFIED MEDICINE OR MEDICAL DEVICE IS SUSPECTED. THE MEDICAL INVESTIGATION EVALUATED THE CASE DESCRIPTION. THE UNISOLVE PRECAUTIONS FOR USE INCLUDE TO USE ONLY AS DIRECTED, FOR EXTERNAL USE ONLY, AND DO NOT APPLY TO OPEN WOUNDS OR MUCOUS MEMBRANES. SMITH AND NEPHEW ARE CONTINUALLY INVESTIGATING WAYS TO DEVELOP AND IMPROVE OUR PRODUCTS AND WE WILL CONTINUE TO MONITOR FOR ANY ADVERSE TRENDS RELATING TO THIS PRODUCT RANGE.
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE PRODUCT, THE PATIENT SUFFERED FROM A BURN.