MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-08-14 for COUPLER, HD, 19.5MM 72201635 manufactured by Smith & Nephew, Inc..
| Report Number | 3003604053-2019-00092 |
| MDR Report Key | 8892629 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-08-14 |
| Date of Report | 2019-09-19 |
| Date Mfgr Received | 2019-09-18 |
| Date Added to Maude | 2019-08-14 |
| 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 | HOLLY TOPPING |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer Phone | 5123913905 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 150 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COUPLER, HD, 19.5MM |
| Generic Name | INSTRUMENT, SPECIAL LENS, FOR ENDOSCOPE |
| Product Code | FEI |
| Date Received | 2019-08-14 |
| Returned To Mfg | 2019-09-11 |
| Catalog Number | 72201635 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 150 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-08-14 |