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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVATEC LIMITED SENSI-CARE¿ STING FREE PROTECTIVE SKIN BARRIER BANDAGE, LIQUID, SKIN PROTECTANT

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CONVATEC LIMITED SENSI-CARE¿ STING FREE PROTECTIVE SKIN BARRIER BANDAGE, LIQUID, SKIN PROTECTANT Back to Search Results
Model Number 420795
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Burn(s) (1757); Skin Discoloration (2074); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Event Date 04/21/2016
Event Type  Injury  
Manufacturer Narrative
Based on the available information, this event is deemed to be a serious injury. No lot number or product evaluation sample is available. A detailed investigation or batch review cannot be conducted. Therefore this evaluation will be closed and will be monitored through our post market product monitoring review process. Information for use states: ensure the sensi-care skin barrier is completely dry before applying adhesive products, such as appliance or wound dressings; warning: highly flammable - keep away from sources of ignition. No smoking; caution: do not use on open wounds. Further follow up information has been requested but not provided to date. Should additional information become available, a follow-up report will be submitted. (b)(4).
 
Event Description
A nurse reporter that a "the patient was in the operating room and one surgeon was applying the product with the 3ml applicator. They thought they were done with the case but the second surgeon noted some bleeding, grabbed a bovie (cautery), and started cauterizing. The first surgeon was still applying the sensicare and thus the product was still wet. There was a spark and the applicator, surgical drape, and patient gown ignited. There was difficulty extinguishing the fire and ultimately water was used to put out the flames. The patient developed blisters requiring a bandage. " reporter stated the patient is male and has "serious cardiac issues affecting his prognosis. The patient was back in surgery today for his cardiac issues. " the patient has blisters present on the chest, and tissues are "turning grey. " reporter stated "cedars leaves the chest open after some procedures. This was open which was why the fellow saw a fatty tissue he wanted to bovie. " the use of other products is unknown. Follow up information received on 05/02/2016 states that the patient sustained 1st and 2nd degree burns. Treatment and outcome are unknown.
 
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Brand NameSENSI-CARE¿ STING FREE PROTECTIVE SKIN BARRIER
Type of DeviceBANDAGE, LIQUID, SKIN PROTECTANT
Manufacturer (Section D)
CONVATEC LIMITED
first avenue
deeside industrial park
deeside, flintshire CH52N U
UK CH52NU
Manufacturer Contact
jeanette johnson
7900 triad center drive
suite 400
greensboro, NC 27409
3365424681
MDR Report Key5664847
MDR Text Key45478136
Report Number1000317571-2016-00044
Device Sequence Number1
Product Code NEC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 04/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number420795
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 Received04/22/2016
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 Unkown

Patient Treatment Data
Date Received: 05/18/2016 Patient Sequence Number: 1
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