MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,08 report with the FDA on 2008-01-15 for TMAX (MAXIMUM EXPOSURE SHOULDER POSITIONER) * manufactured by Tenet Medical Engineering.
[781891]
Event was originally described by facility and entered into maude system. Manufacturer was not aware of the event until a random review of the fda's maude data base. Manufacturer is now reviewing the event and collecting info.
Patient Sequence No: 1, Text Type: D, B5
[7934128]
The mfr became aware of the event through one of our regular searches of the maude database. At this time the mfr does not have any more info than that provided by the data base. The mfr is investigating with the facility that initiated the report as well as a rep of the distributor of the product. Device was returned to distributor and not to mfr.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9681741-2007-00001 |
| MDR Report Key | 1000024 |
| Report Source | 05,07,08 |
| Date Received | 2008-01-15 |
| Date of Report | 2008-01-14 |
| Date of Event | 2007-06-15 |
| Date Mfgr Received | 2007-12-27 |
| Date Added to Maude | 2008-02-21 |
| 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 | 0 |
| Manufacturer Contact | BRENT KING, (V.P. OPERATIONS) |
| Manufacturer Street | 203-11979 40TH ST SE |
| Manufacturer City | CALGARY, AB |
| Manufacturer Country | CA |
| Manufacturer Phone | 5710750 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TMAX (MAXIMUM EXPOSURE SHOULDER POSITIONER) |
| Generic Name | BEACH CHAIR |
| Product Code | BWN |
| Date Received | 2008-01-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 897684 |
| Manufacturer | TENET MEDICAL ENGINEERING |
| Manufacturer Address | * CALGARY, ALBERTA CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-01-15 |