MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a *,08 report with the FDA on 2013-03-07 for DAILY ACTIVITY ASSIST DEVICES 7740 manufactured by Invacare Taylor Street.
[3172956]
One of the chains broke, ref (b)(4) version 2.
Patient Sequence No: 1, Text Type: D, B5
[18564435]
(b)(4). Originally was reported that the manufacturer was unknown but has been corrected to invacare (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1531186-2013-00946 |
| MDR Report Key | 2993573 |
| Report Source | *,08 |
| Date Received | 2013-03-07 |
| Date of Report | 2013-02-11 |
| Date Facility Aware | 2013-02-11 |
| Report Date | 2013-03-07 |
| Date Reported to FDA | 2013-03-07 |
| Date Reported to Mfgr | 2013-03-07 |
| Date Added to Maude | 2013-03-07 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | PATRICIA MEDINA |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE TAYLOR STREET |
| Manufacturer Street | 1200 TAYLOR STREET |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44036 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DAILY ACTIVITY ASSIST DEVICES |
| Generic Name | 890.5050 |
| Product Code | INE |
| Date Received | 2013-03-07 |
| Model Number | 7740 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVACARE TAYLOR STREET |
| Manufacturer Address | 1200 TAYLOR STREET ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-03-07 |