MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BRD SACRUM CTN10; DRESSING,WOUND,OCCLUSIVE

Model Number 66800898

Device Problem Insufficient Information (3190)

Patient Problem Tissue Damage (2104)

Event Date 01/18/2013

Event Type  Injury  

Event Description

Patient experienced skin stripping after allevyn gentle border.

Manufacturer Narrative

(b)(4).

• Brand Name: ALLEVYN GENTLE BRD SACRUM CTN10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2BN; UK HU3 2BN
• Manufacturer Contact: terry mcmahon ; 970 lake carillon dr; st petersburg 33716
• MDR Report Key: 4889805
• MDR Text Key: 6829396
• Report Number: 8043484-2015-00168
• 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: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 66800898
• Device Catalogue Number: 66800898
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/18/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention