MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-02-07 for DAILY ACTIVITY ASSIST DEVICES 6417 manufactured by Invacare Taylor Street.
[3159469]
Provider states patient put weight on left side of table and all screws under right side popped off causing patient to fall and drop phone and ipad, which broke.
Patient Sequence No: 1, Text Type: D, B5
[10501616]
(b)(4). Mdr has been initiated for this issue. The malfunction has not been confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2013-00931 |
| MDR Report Key | 2949225 |
| Report Source | 08 |
| Date Received | 2013-02-07 |
| Date of Report | 2013-02-07 |
| Date Mfgr Received | 2013-01-10 |
| Date Added to Maude | 2013-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MONICA BOONE |
| 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 | INB |
| Date Received | 2013-02-07 |
| Model Number | 6417 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| 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 | 2013-02-07 |