MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-10-15 for CEMENTED AEQUALIS INSTRUMENTATION SET YKAD23 manufactured by Tornier S.a.s..
[162654184]
This is the initial report submitted regarding this surgical event and medical device.
Patient Sequence No: 1, Text Type: N, H10
[162654185]
Upon opening up instruments in theatre it was discovered that the wrong trays had been dispatched to the hospital. The patient was already asleep and there were no sterile sets of the correct instruments in the area. Operation had to be cancelled and patient woken up. Patient was anesthetised and so had to be woken up without surgery having happened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3000931034-2019-00140 |
| MDR Report Key | 9193462 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-10-15 |
| Date of Report | 2019-09-16 |
| Date of Event | 2019-09-16 |
| Date Mfgr Received | 2019-09-18 |
| Date Added to Maude | 2019-10-15 |
| 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 | MS MAUD ANDRIOLLO |
| Manufacturer Street | 161 RUE LAVOISIER |
| Manufacturer City | MONTBONNOT SAINT-MARTIN, 38330 |
| Manufacturer Country | FR |
| Manufacturer Postal | 38330 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEMENTED AEQUALIS INSTRUMENTATION SET |
| Generic Name | ORTHOPEDIC TRAY |
| Product Code | OJH |
| Date Received | 2019-10-15 |
| Catalog Number | YKAD23 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TORNIER S.A.S. |
| Manufacturer Address | 161 RUE LAVOISIER MONTBONNOT SAINT-MARTIN, 38330 FR 38330 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-10-15 |