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 2019-11-25 for R3 20 DEG XLPE ACET LNR 32MM X 50MM 71337650 manufactured by Smith & Nephew, Inc..
| Report Number | 1020279-2019-04151 |
| MDR Report Key | 9372686 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-11-25 |
| Date of Report | 2019-11-25 |
| Date of Event | 2019-10-29 |
| Date Mfgr Received | 2019-10-30 |
| Device Manufacturer Date | 2017-09-01 |
| Date Added to Maude | 2019-11-25 |
| 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 | SMITH & NEPHEW, INC. 1450 BROOKS ROAD |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | R3 20 DEG XLPE ACET LNR 32MM X 50MM |
| Generic Name | PRSTHSS, HIP,SMI-CNSTRIND, UNCMNTD, MTL/PLYMR, POROUS |
| Product Code | MBL |
| Date Received | 2019-11-25 |
| Returned To Mfg | 2019-11-23 |
| Catalog Number | 71337650 |
| Lot Number | 17JM00096 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-25 |