MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-10-08 for QWIX / MESUREUR 119150ND manufactured by Newdeal.
[16833894]
The reporter stated that the large qwix measurer does not measure all the screw lengths that are available in the surgical set. There was no reported harm to a patient.
Patient Sequence No: 1, Text Type: D, B5
[16935861]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9615741-2009-00042 |
| MDR Report Key | 1506492 |
| Report Source | 01,08 |
| Date Received | 2009-10-08 |
| Date of Report | 2009-10-08 |
| Date of Event | 2009-02-01 |
| Date Facility Aware | 2009-02-01 |
| Date Added to Maude | 2010-02-23 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SUSAN SCOTT |
| Manufacturer Street | 311 ENTERPRISE DR |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099363604 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QWIX / MESUREUR |
| Generic Name | NA |
| Product Code | FTY |
| Date Received | 2009-10-08 |
| Catalog Number | 119150ND |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NEWDEAL |
| Manufacturer Address | LYON 69006 FR 69006 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-10-08 |