MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. SOLOSITE WOUND GEL 3OZ; DRESSING, WOUND AND BURN

Model Number GB449600

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/21/2016

Event Type  Injury  

Event Description

It was reported that patient had a split thickness skin graft, mostly healed before using solosite with gauze covering.Solosite applied on (b)(6).By (b)(6) the wound had developed a blistering rash.Dr.Worked with patient to renew healing of the wound with notable improvement.The patient's home care practitioner again applied solosite to the wound and within 24 hours the wound was blistered and denuded, resembling a 2nd degree burn.

Manufacturer Narrative

Please see the attached document containing additional information.

• Brand Name: SOLOSITE WOUND GEL 3OZ
• Type of Device: DRESSING, WOUND AND BURN
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer (Section G): ENCUBE ETHICALS PRIVATE LIMITED; unit no. 24, steelmade indl es; andheri 40005 9; IN 400059
• Manufacturer Contact: claudia odoy ; schachenallee 29; aarau 5001 ; SZ 5001
• MDR Report Key: 5566697
• MDR Text Key: 42380583
• Report Number: 8043484-2016-00039
• Device Sequence Number: 1
• Product Code: MGQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: GB449600
• Device Catalogue Number: GB449600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1