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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER 7.5X7.5CM INT DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66800269
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Injury (2348)
Event Date 01/23/2018
Event Type  Injury  
Event Description
It was reported that a nurse observed exudate leaking from the dressing but the dressing had not absorbed any exudate. She noted maceration around the periwound from the exudate. Used on a non healing cancerous wound and another on a sinus wound.
 
Manufacturer Narrative
Device was not evaluated due to no sample was returned for investigation. Investigation summary: our investigation into this complaint has now concluded. As of today, no additional information requested or sample for this complaint has become available. Without further information we cannot progress our investigation or confirm the details supplied in this complaint. An investigation into the manufacturing paperwork associated with this product code and lot has been carried out. This review detailed that manufacture of the product had occurred in accordance with defined procedures and specifications. No record of any problems occurring during manufacture of the product have been made which may be related to this complaint. Due to the nature of the reported issue this has been passed to one of our medical specialists who has made the following comments. The most recent customer response states, there was "nil maceration observed", "only one wound" and "this is a chronic, ongoing wound with nil changes. " based on the provided information, no further clinical assessment is warranted. 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.
 
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Brand NameALLEVYN GENTLE BORDER 7.5X7.5CM INT
Type of DeviceDRESSING,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
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key7355950
MDR Text Key102990908
Report Number8043484-2018-00058
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number66800269
Device Lot Number201707
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/20/2018
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 Treatment Data
Date Received: 03/20/2018 Patient Sequence Number: 1
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