MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign,user faci report with the FDA on 2017-03-17 for SW-180 manufactured by Ito Co., Ltd. Tsukuba Factory.
[70249580]
The patient had been receiving treatment using the subject device with 40 w output in continuous mode. The subject device burnt the patient on the hip during the thirteenth treatment. According to the hospital, the burn had fully healed by (b)(6) 2014 when ito received the information on the event.
Patient Sequence No: 1, Text Type: D, B5
[72687668]
Ito examined the device history record for the device involved in the adverse event. There were no problems observed during the manufacturing or testing noted in the dhr. Only the oscillator unit was returned to ito. Ito conducted the evaluation of the returned oscillator unit but there was no output from the unit. Ito received a report describing misuse by the user and documented it in the investigation report on the subject device (s/n (b)(4)). Ito reminded the user of the correct use of the device, as described in the user manual.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614750-2017-00007 |
| MDR Report Key | 6412980 |
| Report Source | DISTRIBUTOR,FOREIGN,USER FACI |
| Date Received | 2017-03-17 |
| Date of Report | 2017-03-17 |
| Date of Event | 2014-09-20 |
| Date Mfgr Received | 2014-10-17 |
| Device Manufacturer Date | 2014-01-30 |
| Date Added to Maude | 2017-03-17 |
| 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 | MR. KENNETH BLOCK |
| Manufacturer Street | 1201 RICHARDSON DR. SUITE 160 |
| Manufacturer City | RICHARDSON TX 75080 |
| Manufacturer Country | US |
| Manufacturer Postal | 75080 |
| Manufacturer Phone | 9724809554 |
| Manufacturer G1 | ITO CO., LTD. TSUKUBA FACTORY |
| Manufacturer Street | 3-39-14 UZURANO AMI-MACHI |
| Manufacturer City | INASHIKI-GUN, IBARAKI 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 | SW-180 |
| Generic Name | DIATHERMY, SHORTWAVE, FOR USE IN APPLYING THERAPEUTIC DEEP HEAT |
| Product Code | IMJ |
| Date Received | 2017-03-17 |
| Returned To Mfg | 2014-12-24 |
| Model Number | SW-180 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ITO CO., LTD. TSUKUBA FACTORY |
| Manufacturer Address | 3-39-14 UZURANO AMI-MACHI INASHIKI-GUN, IBARAKI 300-0341 JA 300-0341 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-03-17 |