MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2020-01-11 for UNKNOWN PROFORE manufactured by Smith & Nephew Medical Ltd..
[174780430]
It was reported that the primary objective of this clinical trial (the odyssey trial) was to evaluate the efficacy of two multilayer compression systems in the management of venous and mixed aetiology leg ulcers. This study involved 37 european investigating centres (25 centres in (b)(6), 7 in the (b)(6) and 5 in (b)(6)). In the 4lb control group (profore). During the study, 5 patients presented signs of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00023 |
| MDR Report Key | 9579316 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2020-01-11 |
| Date of Report | 2020-01-11 |
| Date Mfgr Received | 2019-12-16 |
| Date Added to Maude | 2020-01-11 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 0447940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN PROFORE |
| Generic Name | DRESSING, COMPRESSION |
| Product Code | MHW |
| Date Received | 2020-01-11 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL UK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-11 |