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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. NO STING SKIN PREP SPRAY JAPAN

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SMITH & NEPHEW MEDICAL LTD. NO STING SKIN PREP SPRAY JAPAN Back to Search Results
Catalog Number 66800872
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/21/2021
Event Type  Injury  
Event Description
It was reported that the spray pump of the no sting skin prep spray (b)(6) did not work appropriately. When the spray pump was pushed, the liquid was dripping and leaked. The patient was treated with a different technique without delays. The patient was not harmed.
 
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Brand NameNO STING SKIN PREP SPRAY JAPAN
Type of DeviceNO STING SKIN PREP SPRAY JAPAN
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 Key11921059
MDR Text Key253965976
Report Number8043484-2021-01340
Device Sequence Number1
Product Code NEC
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number66800872
Device Lot Number61807
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 06/02/2021 Patient Sequence Number: 1
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