MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-07 for SENSI-CARE STING FREE ADHESIVE RELEASER SPRAY TR101 manufactured by .
[46475416]
Reported to the fda on 05/08/2013. Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
[46475417]
Reported by the complainant as follows... The (b)(6) hospitalized girl had tegaderm on top of emla-creme before blood sampling. The nurse was spraying niltac before removal of the tegaderm. The mother put her hand on the childs arm in order to comfort her and the mother got an electric shock/antistatic reaction. Here after the nurse visualized a flame of 20 cm for less than 5 seconds. The child has no side or late effects of the incidence. The right bend of the arm got a redness about 7 x 7 cm. No burns or blisters. The girl got very scared and shocked. The arm was cooled under running cool water and then added xylocaine on arm. The girl has no permanent marks on the arm but tremendous fear now. She was afraid for blood sampling earlier, before this incident. Mother was shocked and had reported the injury. They have continuous contact with the patient and mother. This communication was received from the user facility. It appeared that a flame had erupted as the liquid product was sprayed on the child's arm and the mother who was holding on to the arm at the arm also felt a 'static shock'. The child is not reported to have suffered any burns injury or any other disfiguring injury to the arm other than 'slight' redness which was cooled with some running water. Xylocaine was also applied (for pain, most likely). Based on this new piece of information, the adverse effect suffered by the patient is no longer deemed serious as there was no report of it leading to a deterioration in health, death, hospitalization or prolongation of hospitalization. However, this complaint is not being treated as a serious malfunction because a recurrence may lead to serious burn injuries to a patient, especially if there was a suitable trigger for the flames. Burns to the skin may require skin grafting or other medical/surgical intervention to treat if flame is not quickly extinguished. The product appropriately has a 'flammable' sign on the container. The product consists of a nonflammable aerosol propellant (134a) but the product concentrate is predominantly made up of a liquid classified as flammable. For this reason, the text on the aerosol does include the flammable symbol. With over one million units of the product sold, no similar incidence has been reported to the company in the past. Whilst any flammable liquid could theoretically produce a vapor concentration that may be flammable as it evaporates, unfortunately the account does not provide any information regarding any other possible sources of flammable vapors or ignition sources. For example; was any electric equipment being used in the vicinity or what other substances were being used i. E. Were alcohol swabs used to clean the surrounding area of the dressing or even alcohol gel used on the nurses hands before starting the procedure, either could have provided a flammable vapor cloud which could have been ignited by a suitable ignition source. From a clinical perspective, a causal relationship between the adhesive remover spray and this event is deemed possible because product use is temporally associated with the skin where the problem occurred. The current risk assessment includes the risk of ignition and this is mitigated by warnings on the label.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1000317571-2013-00002 |
| MDR Report Key | 3104635 |
| Date Received | 2013-05-07 |
| Date of Report | 2013-04-09 |
| Date of Event | 2013-04-09 |
| Date Mfgr Received | 2013-04-09 |
| Date Added to Maude | 2013-05-10 |
| 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 | KATRINA FIEDLER |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042541 |
| Manufacturer G1 | CONVATEC LIMITED |
| Manufacturer Street | FIRST AVE. DEESIDE INDUSTRIAL PARK |
| Manufacturer City | DEESIDE, FLINTSHIRE CH5 2NU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | CH5 2NU |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SENSI-CARE STING FREE ADHESIVE RELEASER SPRAY |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2013-05-07 |
| Model Number | TR101 |
| Catalog Number | TR101 |
| Lot Number | 012322 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-05-07 |