MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GB MULTISITE CTN 5; DRESSING,WOUND,OCCLUSIVE

Catalog Number 66800959

Device Problem Insufficient Information (3190)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 07/24/2019

Event Type  Injury  

Event Description

It was reported that there was an enlargement of ulcer due to exudate.

Event Description

It was reported that there was an enlargement of ulcer due to exudate.Patient was hospitalized to intensify wound treatment.Wound has worsened due to high exudate.Compression therapy has to be started.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.As no samples were provided, a product evaluation could not be carried out.However, the failure mode was confirmed from images provided.A clinical assessment was carried out.It was concluded: ¿the photo provided confirms the dressing with exudate but not a root cause.Based on the information provided we are unable to determine whether the enlargement of ulcer was due to a pre-existing or concurrent medical condition or procedural variance during use of the product.The dressing appeared to function as designed and therefore, causal relationship between the smith and nephew device and the reported issue cannot be confirmed.No further clinical assessment can be rendered at this time.¿ tests are carried out on retained examples of the finished product once they have been manufactured.The tests results for lot 201844 found that all product was within specification.A risk management review was carried out for this product.The dressing appeared to function as designed and therefore no further action is required at this stage.As stated in the ifu for this product relating to pressure ulcers; frequently inspect the skin for pressure damage by lifting back one corner, inspecting and then repositioning the dressing.On this occasion we have been unable to confirm the failure mode and subsequently identify a root cause.A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant.In addition it can be confirmed that all finished product specification testing was satisfied at the point of release.

Event Description

It was reported that there was an enlargement of ulcer due to exudate.Patient was hospitalized.

• Brand Name: ALLEVYN GB MULTISITE CTN 5
• Type of Device: DRESSING,WOUND,OCCLUSIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull ; UK
• MDR Report Key: 8904481
• MDR Text Key: 154686700
• Report Number: 8043484-2019-00582
• Device Sequence Number: 1
• Product Code: NAD
• Combination Product (y/n): N
• PMA/PMN Number: K112127
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 66800959
• Device Lot Number: 201844
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention