MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-08-08 for DAILY ACTIVITY ASSIST DEVICES 9650-4 manufactured by Invamex.
[2847829]
Dealer called stating that the seat on the 9650-4 commode allegedly cracked on the left side and would separate when the consumer sat down. No injury alleged.
Patient Sequence No: 1, Text Type: D, B5
[10108058]
(b)(4) - mo rma has been initiated for this issue. Model 9650-4, serial number/date code m10425. The owner's manual part number 1148075 was issued with this device. The owner's manual is also found on-line at invacare. Com. It is unknown if the consumer has fully read and understands the owner's manual. Documentation provides warnings, cautions, and instructions for safely using the device. If the consumer does not understand the written warnings, cautions or instructions then they should contact invacare. The consumer is a (b)(6) female. The consumer's medical condition, stability and medication regimen are unknown. The consumer's technique while using the device is unknown. The maintenance history of the device is unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616091-2012-00238 |
| MDR Report Key | 2687603 |
| Report Source | 08 |
| Date Received | 2012-08-08 |
| Date of Report | 2012-08-08 |
| Date Mfgr Received | 2012-07-12 |
| Date Added to Maude | 2012-11-28 |
| 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 | KAREN LOUGHREN |
| Manufacturer Street | ONE INVACARE WAY |
| Manufacturer City | ELYRIA OH 44035 |
| Manufacturer Country | US |
| Manufacturer Postal | 44035 |
| Manufacturer Phone | 8003336900 |
| Manufacturer G1 | INVAMEX |
| Manufacturer Street | P O DRAWER BB |
| Manufacturer City | HIDALGO TX 78557 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 78557 |
| 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 | 2012-08-08 |
| Model Number | 9650-4 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INVAMEX |
| Manufacturer Address | P O DRAWER BB HIDALGO TX 78557 US 78557 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-08-08 |