MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a * report with the FDA on 2015-01-16 for 3 POSITION RECLINER DLX-X WIDE BLUE RIDGE 9153641314 IH6065WD/IH61 manufactured by Goodbaby.
[5283906]
The caller states that the ratchet has broken on the chair. (b)(4) was previous complaint for the same part breaking. Dealer states, his patient states that something is bent in the back of the chair where the push handle attaches to the chair.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1531186-2015-00349 |
| MDR Report Key | 4429262 |
| Report Source | * |
| Date Received | 2015-01-16 |
| Date of Report | 2015-01-07 |
| Date Facility Aware | 2015-01-07 |
| Report Date | 2015-01-16 |
| Date Reported to FDA | 2015-01-16 |
| Date Reported to Mfgr | 2015-01-16 |
| Date Added to Maude | 2015-01-20 |
| 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 DLX-X WIDE BLUE RIDGE 9153641314 |
| Generic Name | CHAIR AND TABLE, MEDICAL |
| Product Code | KMN |
| Date Received | 2015-01-16 |
| Model Number | IH6065WD/IH61 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | 2 YR |
| 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 | 2015-01-16 |