MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-04-16 for DAILY ACTIVITY ASSIST DEVICES-UTENSIL FOR DRESSING, GROOMING, RECREAT 7740P manufactured by Invacare.
[1522719]
The facility states there were two employees assisting the consumer. The consumer was holding the trapeze bar and pulling down when the vertical bar allegedly bent, causing the device to bend forward and hit the employee assistant on the head. This allegedly resulted in a concussion to the employee.
Patient Sequence No: 1, Text Type: D, B5
[8470103]
A medwatch form was received on 04/05/2010 (b) (6) providing add'l info. No injury to the pt has occurred. Photos were provided, and it is apparent the trapeze was not assembled properly. The facility indicates the device was assembled by the distributor within this medwatch form. Photos provided indicated that the device was not fully seated in the base. The facilities attendant allegedly sustained an injury. No malfunction apparent. Mdr filed as a conservative measure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1525712-2010-00050 |
| MDR Report Key | 1662394 |
| Report Source | 06 |
| Date Received | 2010-04-16 |
| Date of Report | 2010-04-16 |
| Date of Event | 2010-02-22 |
| Date Mfgr Received | 2010-04-05 |
| Device Manufacturer Date | 2009-08-01 |
| Date Added to Maude | 2010-04-21 |
| 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 | RON CLINES |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44036 |
| Manufacturer Country | US |
| Manufacturer Postal | 44036 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVACARE |
| Manufacturer Street | ONE INVACARE WAY |
| 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-UTENSIL FOR DRESSING, GROOMING, RECREAT |
| Generic Name | 890.5050 |
| Product Code | ILZ |
| Date Received | 2010-04-16 |
| Model Number | 7740P |
| Lot Number | RP090814 |
| 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 |
| Manufacturer Address | ELYRIA OH 44036 US 44036 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-04-16 |