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 2020-03-29 for UNKNOWN OPSITE POST-OP manufactured by Smith & Nephew Medical Ltd..
[185727681]
It was reported that in a pilot randomized trial to evaluate the feasibility of conducting a fully powered randomized controlled trial to investigate the effectiveness of dacc-coated post-operative dressings in the reduction of surgical site infection in vascular surgical patients, the patients were randomized on the day of their surgical procedure to receive post-operative dressing with a dacc-coated dressing (leukomed? Sorbact? , bsn medical, hull, uk), or a non-coated occlusive absorbent control post-operative dressing (standard practice) (opsite? Post-op, smith & nephew, hull, uk). It was stated that 18 patients in the opsite post-op group had a surgical site infection at 30 days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00237 |
| MDR Report Key | 9896235 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-29 |
| Date of Report | 2020-03-29 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-29 |
| 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 OPSITE POST-OP |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-03-29 |
| 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 HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-29 |