MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2006-08-15 for PERFORMA TM-300 A501009 manufactured by Ito Co., Ltd..
[496886]
From a letter dated 06/09/06 received from an attorney representing the patient, it is claimed that the patient "was on traction equipment" at a user facility in 2004, when the device "malfunctioned, causing serious injury to both of [patient]'s shoulders. " letter was sent to manufacturer and distributor, but with no additional information regarding patient condition, use conditions, or other relevant details. It is yet unknown whether claimed injury was temporary or is permanent.
Patient Sequence No: 1, Text Type: D, B5
[7788435]
Device evaluation is not possible yet. Initial report was received from patient's attorney approximately two (2) years after the claimed adverse event. Distributor initially contacted user facility, but was unsuccessful in either confirming event or gathering further details regarding event. U. S. Agent for manufacturer is now directly seeking additional information from user facility regarding use conditions, patient outcome, and location/condition/availability of device for evaluation. Report update(s) shall be submitted when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614750-2006-00001 |
| MDR Report Key | 751856 |
| Report Source | 00 |
| Date Received | 2006-08-15 |
| Date of Report | 2006-08-14 |
| Date of Event | 2004-07-06 |
| Date Mfgr Received | 2006-06-09 |
| Device Manufacturer Date | 2003-03-01 |
| Date Added to Maude | 2006-08-21 |
| 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 | KENNETH BLOCK, U.S. AGENT |
| Manufacturer Street | 3608 CHRISTOPHER LN. |
| Manufacturer City | RICHARDSON TX 75082 |
| Manufacturer Country | US |
| Manufacturer Postal | 75082 |
| Manufacturer Phone | 2144481859 |
| Manufacturer G1 | ITO CO., LTD. |
| Manufacturer Street | 3-39-14 UZARANO, AMI-MACHI INASHIKI-GUN |
| Manufacturer City | IBARAKI-KEN 300-0341 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 300-0341 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERFORMA |
| Generic Name | EQUIPMENT, TRACTION, POWERED (ITH) |
| Product Code | ITH |
| Date Received | 2006-08-15 |
| Model Number | TM-300 |
| Catalog Number | A501009 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 739655 |
| Manufacturer | ITO CO., LTD. |
| Manufacturer Address | INASHIKI-GUN IBARAKI-KEN JA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2006-08-15 |