MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2015-07-03 for ACTICOAT BURN 40X40 66000794 manufactured by Smith & Nephew Medical Ltd..
[6067384]
It was reported that bacteria was present on the dressing.
Patient Sequence No: 1, Text Type: D, B5
[14497714]
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8043484-2015-00180 |
| MDR Report Key | 4889834 |
| Report Source | 07 |
| Date Received | 2015-07-03 |
| Date of Report | 2013-04-03 |
| Date of Event | 2013-04-03 |
| Date Mfgr Received | 2013-04-03 |
| Date Added to Maude | 2015-07-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR TERRY MCMAHON |
| Manufacturer Street | 970 LAKE CARILLON DR, |
| Manufacturer City | ST PETERSBURG FL 33716 |
| Manufacturer Country | US |
| Manufacturer Postal | 33716 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE RD |
| Manufacturer City | HULL HU32BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACTICOAT BURN 40X40 |
| Generic Name | ACTICOAT 40X40CM CTN 6 |
| Product Code | MGP |
| Date Received | 2015-07-03 |
| Model Number | 66000794 |
| Catalog Number | 66000794 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE RD HULL HU32BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-07-03 |