MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2011-10-18 for ACHILLES EXPRESS manufactured by Ge Medical Systems (china) Co., Ltd..
[2219669]
It was reported that the 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 by the site and stated that the pain was still present. The extent of the alleged injury has not been made available.
Patient Sequence No: 1, Text Type: D, B5
[9366660]
(b)(4). The exact incident date was not reported. The event could not be isolated to a single device. All achilles express operated by the site prior to the date of the event: serial # (b)(4), device mfr date: 11/2010, serial # (b)(4), device mfr date: 12/2010. Serial # (b)(4), device mfr date: 12/2010. A ge healthcare field engineer visited the site and evaluated 4 units that were operated by the site during the approximate time of the event. The 4 units were tested and met product specification. There are no indications of device malfunction. The device history records of the 4 units were reviewed, all met production requirements. No further actions are planned at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9710602-2011-00001 |
| MDR Report Key | 2307991 |
| Report Source | 06 |
| Date Received | 2011-10-18 |
| Date of Report | 2011-10-18 |
| Date of Event | 2011-03-28 |
| Date Mfgr Received | 2011-04-19 |
| Device Manufacturer Date | 2010-11-01 |
| Date Added to Maude | 2011-10-28 |
| 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 SANSALLA |
| Manufacturer Street | 3000 N. GRANDVIEW BLVD. W450 |
| Manufacturer City | WAUKESHA WI 53188 |
| Manufacturer Country | US |
| Manufacturer Postal | 53188 |
| Manufacturer Phone | 2625482661 |
| Manufacturer G1 | GE MEDICAL SYSTEMS (CHINA) CO. LTD. |
| Manufacturer City | WUXI, JIANGSU |
| 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 | KGI |
| Date Received | 2011-10-18 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE MEDICAL SYSTEMS (CHINA) CO., LTD. |
| Manufacturer Address | WUXI, JIANGSU CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-10-18 |