MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-29 for CANNULA,OUTFLOW,3MM 7204863 manufactured by Smith & Nephew, Inc..
[96124140]
Patient Sequence No: 1, Text Type: N, H10
[96124141]
It was reported that part of an outflow cannula was found on a postoperative x-ray.
Patient Sequence No: 1, Text Type: D, B5
[118803408]
Additional information received by smith & nephew revealed that we are not the manufacturer of the reported device associated with this complaint. This report was made based upon information which smith & nephew had not been able to investigate or verify prior to the required reporting date. Smith & nephew wishes to withdraw this mdr report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219602-2017-01611 |
| MDR Report Key | 7154238 |
| Date Received | 2017-12-29 |
| Date of Report | 2018-01-10 |
| Date Mfgr Received | 2018-01-09 |
| Date Added to Maude | 2017-12-29 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 130 FORBES BOULEVARD |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02048 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CANNULA,OUTFLOW,3MM |
| Generic Name | INSTRUMENT, SURGICAL, ORTHOPEDIC, DC-POWERED MOTOR AND ACCESSORY/ATTACHMENT |
| Product Code | KIJ |
| Date Received | 2017-12-29 |
| Catalog Number | 7204863 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 130 FORBES BOULEVARD MANSFIELD MA 02048 US 02048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-29 |