MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 12.5 X 12.5 CTN 10; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800272

Device Problem Suction Problem (2170)

Patient Problem Injury (2348)

Event Date 01/19/2018

Event Type  Injury  

Event Description

It was reported that with moist wounds, the dressings are not wicking away the moisture.The moisture is causing maceration of the skin, which increases skin injuries.

Manufacturer Narrative

We have now concluded our investigation into this complaint.As of today, no sample requested for this complaint has become available.Without further information or a sample we cannot progress our investigation or confirm the details supplied in this complaint.The free swell absorption of all batches are tested at the time of release unless the results are within specification the batch is not released, unfortunately as no specific lot number has been provided we are unable to provide specific results.A review of the associated batch manufacturing records was not possible due to no lot number being supplied.Due to the nature of the reported issue, this has been passed to one of our medical specialists who has made the following comments ¿several attempts have been made to obtain clinical/medical documents to no avail.Without supporting clinical/medical documents a thorough investigation cannot be performed.Should information become available this complaint can be re-assessed¿ in the absence of additional information, our investigation remains inconclusive.At this time an exact root cause cannot be determined.If additional information becomes available in the future, this case will be reopened.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.We will continue to monitor for any adverse trends relating to this product range.

• Brand Name: ALLEVYN GENTLE BORDER 12.5 X 12.5 CTN 10
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer (Section G): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 8N; UK HU3 28N
• Manufacturer Contact: sarah freestone ; 101 hessle road; hull HU3 2-BN ; UK HU3 2BN
• MDR Report Key: 7559094
• MDR Text Key: 109736132
• Report Number: 8043484-2018-00124
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800272
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2018
• 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