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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20 DRESSING,WOUND,OCCLUSIVE

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SMITH & NEPHEW MEDICAL LTD. OPSITE POST OP 9.5X8.5CM CTN 20 DRESSING,WOUND,OCCLUSIVE Back to Search Results
Catalog Number 66000709
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/28/2019
Event Type  malfunction  
Event Description
It was reported that the product is not waterproof and it did not stick properly. It is unknown which procedure was being performed, when the event happened, if there was patient involvement, if there was a delay in the case and if a backup device was available. Further information is not available.
 
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Brand NameOPSITE POST OP 9.5X8.5CM CTN 20
Type of DeviceDRESSING,WOUND,OCCLUSIVE
Manufacturer (Section D)
SMITH & NEPHEW MEDICAL LTD.
101 hessle road
hull
UK
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
0447940038
MDR Report Key9517043
MDR Text Key174182257
Report Number8043484-2019-00950
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,health
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66000709
Device Lot NumberUNKNOWN
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 Received03/12/2021
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

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