MAUDE Adverse Event Report: SMITH & NEPHEW INC. ALLEVYN GENTLE BORDER & LIFE SACRAL DRESSINGS; DRESSING WOUND, OCCLUSIVE

Model Number QUADRILOBE

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Silicone from dressing remained on patient's skin after the dressing was removed and the silicone had to be picked off the patient's skin.This was first reported in (b)(6) and (b)(6) involving 4 patients at this facility.On (b)(6) 2018 allevyn gentle border 5x5 silicone foam dressing silicone was left on skin; on (b)(6) 2018 allevyn life sacral dressing silicone from the backing was left behind and had to be manually picked off of patient's skin and wound.On (b)(6) 2018 allevyn life sacral dressing, a lot of silicone was left behind on a patient's wound.Allevyn life.

• Brand Name: ALLEVYN GENTLE BORDER & LIFE SACRAL DRESSINGS
• Type of Device: DRESSING WOUND, OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW INC.
• MDR Report Key: 8277874
• MDR Text Key: 134457453
• Report Number: MW5083383
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/11/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: QUADRILOBE
• Device Catalogue Number: 66801070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1