MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNISOLVE 8.0 OZ BTL 01; ABSORBER, CARBON-DIOXIDE

Catalog Number 59402500

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 01/09/2019

Event Type  Injury  

Event Description

It was reported that during use of the product, the patient suffered from a burn.

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.

• Brand Name: UNISOLVE 8.0 OZ BTL 01
• Type of Device: ABSORBER, CARBON-DIOXIDE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8312934
• MDR Text Key: 135239007
• Report Number: 8043484-2019-00087
• Device Sequence Number: 1
• Product Code: BSF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 06/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 04/30/2023
• Device Catalogue Number: 59402500
• Device Lot Number: 57445
• Date Manufacturer Received: 06/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 4 YR