MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-01-27 for 3 POSITION RECLINER (BASIC) JADE 9153641335 IH6074A manufactured by Goodbaby.
[5322653]
Bill states the chair was sent to the facility and ordered by a family member for the end user out of state, when delivered the right side frame was bent and all the way down the front castor is inward about three inches,out of box. Bill stated no damage to the box and chair has not been used by the end user. Bill was given the number to the provider belnick,inc to contact for service, bill states he did not have a contact number for the family member who ordered the chair, bill will contact the provider directly. No further information provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2015-00595 |
| MDR Report Key | 4457139 |
| Report Source | * |
| Date Received | 2015-01-27 |
| Date of Report | 2015-01-21 |
| Date of Event | 2015-01-20 |
| Date Facility Aware | 2015-01-21 |
| Report Date | 2015-01-26 |
| Date Reported to FDA | 2015-01-26 |
| Date Reported to Mfgr | 2015-01-26 |
| Date Added to Maude | 2015-01-27 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3 POSITION RECLINER (BASIC) JADE 9153641335 |
| Generic Name | CHAIR AND TABLE, MEDICAL |
| Product Code | KMN |
| Date Received | 2015-01-27 |
| Model Number | IH6074A |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GOODBABY |
| Manufacturer Address | CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-01-27 |