MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-05-19 for ACHILLES EXPRESS manufactured by Ge Hangwei Medical Systems Co.
[2002726]
It was reported that a woman scanned on an achilles express experienced ankle pain following a test that was administered at a health food store. Three weeks later she was contacted and stated that the pain was still present. The extent of the alleged injury has not been determined. The woman has not been evaluated by a medical professional.
Patient Sequence No: 1, Text Type: D, B5
[9051222]
Ge healthcare's investigation into the reported occurrence is ongoing. A follow up report will be submitted when the investigation has been completed. Pt age and weight are not known at this time. Date approximated as 3 weeks before (b)(4) 2011. The exact incident date has not been reported. Serial number has not been made available. Device manufacture date cannot be determined without a serial number.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613445-2011-00005 |
| MDR Report Key | 2098580 |
| Report Source | 06 |
| Date Received | 2011-05-19 |
| Date of Report | 2011-05-19 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-04-19 |
| Date Added to Maude | 2011-05-25 |
| 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 | JOY SONSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE HANGWEI MEDICAL SYSTEMS CO |
| Manufacturer City | BEIJING |
| Manufacturer Country | CH |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ACHILLES EXPRESS |
| Generic Name | BONE SONOMETER |
| Product Code | MUA |
| Date Received | 2011-05-19 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HANGWEI MEDICAL SYSTEMS CO |
| Manufacturer Address | BEIJING CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-05-19 |