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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN GENTLE BORDER DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. UNKNOWN ALLEVYN GENTLE BORDER DRESSING,WOUND,OCCLUSIVE Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem Injury (2348)
Event Date 04/05/2019
Event Type  Injury  
Event Description
It was reported that in a heel post a pressure injury. Competitor dressing applied - initially was an eschar insitu. (b)(6) did a small debridement and removed the eschar. Then applied allevyn gentle border. (b)(6) when did dressing change noticed that exudate had pooled underneath the allevyn gentle border and resulted in maceration. White saturated wound edges - was using aquacel ag underneath the allevyn gentle border at time. Stated that the allevyn gentle border does not absorb exudate properly.
 
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Brand NameUNKNOWN ALLEVYN GENTLE BORDER
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull HU3 2 BN
UK HU3 2BN
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
4407940038
MDR Report Key8566218
MDR Text Key143597626
Report Number8043484-2019-00301
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 06/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received04/08/2019
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: 04/30/2019 Patient Sequence Number: 1
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