MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-02-04 for RELEASE AGENT 413500 manufactured by Convatec Inc.
[181945085]
Based on the available information, this event is deemed to be a reportable malfunction. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[181945086]
It was reported "the nurse was preparing the patient for discharge and was ready to remove her hep -lock. He opened the gauze and then opened the adhesive remover wipe. The wipe immediately caught fire. The flames went up his right arm and he was able to pat them out. He was standing about two feet away from the patient at the time. " the nurse was asked if there was a possible ignition source and he stated he was wondering if it could be static. Patient and a patient's family member were present when this occurred. Patient was not on oxygen and he was not in the unit, he was in a room on a standard patient floor. " there were no chemicals or heat sources around the area, and no alcohol or paraffin was involved. No smart watch or phone was in use or nearby during the incident. Additional information received on 01/14/2020, reporting the nurse? S injury was a first degree burn to his right hand and singeing of the hair on his right forearm. The nurse was treated in the emergency room, that included rinsing the area twenty minutes with cold water, then applied bacitracin and dressed. It was recommended for the nurse to follow-up with general surgeon examination in two to three days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2020-00043 |
| MDR Report Key | 9665983 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-02-04 |
| Date of Event | 2020-01-10 |
| Date Mfgr Received | 2020-01-10 |
| Date Added to Maude | 2020-02-04 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | CONVATEC INC |
| Manufacturer Street | 211 AMERICAN AVENUE |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 27409 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELEASE AGENT |
| Generic Name | SOLVENT, ADHESIVE TAPE |
| Product Code | KOX |
| Date Received | 2020-02-04 |
| Model Number | 413500 |
| Lot Number | T2035 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC |
| Manufacturer Address | 211 AMERICAN AVENUE GREENSBORO NC 27409 US 27409 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-04 |