MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-10 for RUSH81 NA manufactured by Ability Dynamics Llc.
[4666139]
Per (b)(6)'s prosthetist, on (b)(6) 2014 on a phone call conversation to ability dynamics, the following was reported: (b)(6) was at school and stopped to tie his shoe. When he arose and began to hurry to catch up with friends, his rush81 foot broke. When the last bolt broke, the upper portion of the bracket separated from the keel or upper composite piece. This left david with only a portion of the foot still attached to his prosthesis. David stumbled, but there was no report of him falling. There were no injuries, and to the best of our knowledge, (b)(6) did not see a physician.
Patient Sequence No: 1, Text Type: D, B5
[11967652]
Email sent from (b)(4) (ability) (b)(4) 2014. Requested the return of the broken rush81 foot with all components. Told (b)(6) he would be informed of the outcome of the investigation. Told (b)(6), ability is sending replacement rush81 and rush87 feet to see which works best. Email sent from (b)(6) 2014. Received the feet and is calling in the patient. Email sent to (b)(6) 2014: (b)(4) confirmed this was covered by warranty. (b)(4) told (b)(6) there would be a thorough investigation. (b)(4) also expressed that ability takes safety very seriously. Email received to (b)(4) 2014: (b)(6) communicated that he successfully installed, onto (b)(6), a rush87 replacement foot ability had sent. Prosthetist and patient were pleased. Call (b)(4) 2014: (b)(4). Confirmed everything went well and both prosthetist and patient are satisfied.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3008584163-2014-00001 |
| MDR Report Key | 3916350 |
| Report Source | 05 |
| Date Received | 2014-06-10 |
| Date of Report | 2014-06-06 |
| Date of Event | 2014-05-14 |
| Date Mfgr Received | 2014-05-19 |
| Device Manufacturer Date | 2014-02-26 |
| Date Added to Maude | 2014-07-17 |
| 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 | 0 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2082 E UNIVERSITY DR |
| Manufacturer City | TEMPE AZ 852810000 |
| Manufacturer Country | US |
| Manufacturer Postal | 852810000 |
| Manufacturer Phone | 4803611714 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSH81 |
| Generic Name | PROSTHETIC FOOT |
| Product Code | ISH |
| Date Received | 2014-06-10 |
| Returned To Mfg | 2014-05-19 |
| Model Number | 81 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2017-02-26 |
| 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 | ABILITY DYNAMICS LLC |
| Manufacturer Address | TEMPE AZ US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-06-10 |