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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER SACRUM CTN10 DRESSING, WOUND, OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. ALLEVYN GENTLE BORDER SACRUM CTN10 DRESSING, WOUND, OCCLUSIVE Back to Search Results
Model Number 66020413
Device Problem Material Integrity Problem (2978)
Patient Problems Bacterial Infection (1735); Pain (1994); Skin Infection (4544)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the adhesive quality is not good. The dressing is peeling at the top and sides. Dressing was placed on cox's (lower back), it was checked by dn who confirmed there was no creams or moisturizers which may have caused this adhesive to unstick so soon. The wound is currently infected with staphylococcus after a swab was taken on 21st october. Customer started a course of antibiotics on oct 28th.
 
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Brand NameALLEVYN GENTLE BORDER SACRUM CTN10
Type of DeviceDRESSING, WOUND, OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer (Section G)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull east riding of yorkshire HU3 2 BN
UK HU3 2BN
Manufacturer Contact
holly topping
7000 west william cannon drive
austin, TX 78735
5123913905
MDR Report Key10905747
MDR Text Key218627288
Report Number8043484-2020-03973
Device Sequence Number1
Product Code NAD
Combination Product (y/n)N
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/25/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number66020413
Device Catalogue Number66800898
Device Lot Number202027
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2020
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: 11/25/2020 Patient Sequence Number: 1
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