MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-02-09 for INDEGO 501-100-000 manufactured by Parker Hannifin Human Motion And Control.
[67290542]
Investigation of returned device completed 12-30-16. Determined that 2 screw bosses at hip joint were cracked. Determined that 4 upper leg cover screws were missing [not installed during assembly]. These 2 causes together contributed to reduction of lateral stability observed in this event. The reduction in lateral stability in this incident is deemed to be an isolated event due to the isolated assembly defect found in this device.
Patient Sequence No: 1, Text Type: N, H10
[67290543]
Clinician training a personal user reported plastic cover separation on upper leg component and reduction in lateral stability. No fall or injury occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012247114-2017-00001 |
| MDR Report Key | 6314472 |
| Date Received | 2017-02-09 |
| Date of Report | 2016-12-09 |
| Date of Event | 2016-12-09 |
| Date Mfgr Received | 2016-12-09 |
| Device Manufacturer Date | 2016-11-23 |
| Date Added to Maude | 2017-02-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CRAIG MIKIN |
| Manufacturer Street | 1390 HIGHLAND ROAD E |
| Manufacturer City | MACEDONIA OH 44056 |
| Manufacturer Country | US |
| Manufacturer Postal | 44056 |
| Manufacturer Phone | 8002727537 |
| Manufacturer G1 | PARKER HANNIFIN HUMAN MOTION AND CONTROL |
| Manufacturer Street | 1390 HIGHLAND ROAD E |
| Manufacturer City | MACEDONIA OH 44056 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44056 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INDEGO |
| Generic Name | POWERED EXOSKELETON |
| Product Code | PHL |
| Date Received | 2017-02-09 |
| Returned To Mfg | 2016-12-30 |
| Model Number | 501-100-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PARKER HANNIFIN HUMAN MOTION AND CONTROL |
| Manufacturer Address | 1390 HIGHLAND ROAD E MACEDONIA OH 44056 US 44056 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-02-09 |