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

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.

• Brand Name: SENSI-CARE¿ STING FREE PROTECTIVE SKIN BARRIER
• Type of Device: BANDAGE, 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 Key: 5664847
• MDR Text Key: 45478136
• Report Number: 1000317571-2016-00044
• Device Sequence Number: 1
• Product Code: NEC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• 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 Received: 05/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 420795
• 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 Received: 04/22/2016
• 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