MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-03-28 for SECURA NO-STING BARRIER FILM 3MLX50SWABS 66800711 manufactured by Smith & Nephew Medical Ltd..
[103643241]
Patient Sequence No: 1, Text Type: N, H10
[103643242]
It was reported that secure was used on the wound edge when using npwt system. Small wound leakages noticed and electrode switchpen used to stop bleeding. Vapor was lit on fire. No patient harm reported.
Patient Sequence No: 1, Text Type: D, B5
[107863077]
The device was not evaluated due to samples were not returned for investigation. Investigation results: we have now concluded our investigation into this report of skin prep no sting wipes. It can be confirmed that each batch released to market undergoes full testing as outlined in the finished product specification, and must comply with all the requirements. The associated skin prep no sting wipe product information for use (ifu) leaflet states the following: secura no-sting barrier films is flammable: use in a well-ventilated area. Avoid using around flames and sources of ignition. Keep out of the reach of children. For external use only. Additionally, complaints of a similar nature will be closely monitored for any adverse trends and further action considered.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2018-00072 |
| MDR Report Key | 7376527 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-03-28 |
| Date of Report | 2018-05-09 |
| Date of Event | 2018-03-02 |
| Date Mfgr Received | 2018-03-05 |
| Date Added to Maude | 2018-03-28 |
| 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 | MR MARKUS POETTKER |
| Manufacturer Street | SCHACHENALLEE 29 |
| Manufacturer City | AARAU 5001 |
| Manufacturer Country | SZ |
| Manufacturer Postal | 5001 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 28N |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 28N |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SECURA NO-STING BARRIER FILM 3MLX50SWABS |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KMF |
| Date Received | 2018-03-28 |
| Catalog Number | 66800711 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 28N UK HU3 28N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-28 |