MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-05-18 for SENSI-CARE? STING FREE PROTECTIVE SKIN BARRIER 420795 manufactured by Convatec Limited.
[45478136]
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).
Patient Sequence No: 1, Text Type: N, H10
[45478137]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2016-00044 |
| MDR Report Key | 5664847 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-05-18 |
| Date of Report | 2016-04-22 |
| Date of Event | 2016-04-21 |
| Date Mfgr Received | 2016-04-22 |
| Date Added to Maude | 2016-05-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SENSI-CARE? STING FREE PROTECTIVE SKIN BARRIER |
| Generic Name | BANDAGE, LIQUID, SKIN PROTECTANT |
| Product Code | NEC |
| Date Received | 2016-05-18 |
| Model Number | 420795 |
| Operator | NURSE |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH52NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-18 |