MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN ADH 7.5CM X 7.5CM 10S CN; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800759

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

Patient Problem Injury (2348)

Event Date 10/18/2019

Event Type  Injury  

Event Description

It was reported in a patient with skin prone to develop pressure ulcers the skin turned red at the acromion.In order to prevent further deterioration and skin lesion, the nurse applied alleveyn adhesive for one week.When the dressing was removed, the skin was found a lesion of 0.5 cm x 0.5 cm.Immediately sprayed epidermal growth factor, and coated with mercurochrome.The skin gradually healed and further information was not provided.

• Brand Name: ALLEVYN ADH 7.5CM X 7.5CM 10S CN
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN ; 0447940038
• MDR Report Key: 9391692
• MDR Text Key: 168436708
• Report Number: 8043484-2019-00873
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800759
• Device Lot Number: 201835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 82 YR