MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2013-03-05 for ALTERG ANTI-GRAVITY TREADMILL M320 manufactured by Alterg Inc.
[3175010]
Customer reported that 5 student athletes contracted a staph infection transmitted through the sharing of shorts while using the alterg anti-gravity treadmill. Per the customer: about 5 cases. Diagnosed by a medical doctor. Happens with college age female athletes who have some chafing issues between their legs. The staph makes the problem a lot worse.
Patient Sequence No: 1, Text Type: D, B5
[10518197]
Per statements from customer, multiple uses of the shorts garment were happening between wash cycles. The impacted facility hired someone to come in and test the ph of the water. They are confident in the disinfecting at the water temp they are now using (no longer cold water) will resolve the issue. The site has also bought more shorts garments to eliminate the need for sharing of the garments between wash cycles. Alterg will evaluate the labeling instructions for appropriate handling and use of shorts to users; updating instructions as appropriate. Alterg will continue to track this issue in our complaint system for re-occurrence as well as effectiveness of any changes implemented.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007033433-2013-00001 |
| MDR Report Key | 2994433 |
| Report Source | 04 |
| Date Received | 2013-03-05 |
| Date of Report | 2013-03-05 |
| Date of Event | 2013-02-14 |
| Date Mfgr Received | 2013-02-14 |
| Device Manufacturer Date | 2012-01-01 |
| Date Added to Maude | 2013-03-11 |
| 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 | MIKE PHILLIPS, VP |
| Manufacturer Street | 48438 MILMONT DRIVE |
| Manufacturer City | FREMONT CA 945380000 |
| Manufacturer Country | US |
| Manufacturer Postal | 945380000 |
| Manufacturer Phone | 5102705890 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALTERG ANTI-GRAVITY TREADMILL |
| Product Code | BXB |
| Date Received | 2013-03-05 |
| Model Number | M320 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALTERG INC |
| Manufacturer Address | 48438 MILMONT DRIVE FREMONT CA 94538 US 94538 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-05 |