MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2002-05-10 for INVACARE BEDS UNKBEDRAIL * manufactured by Invamex - Invacare Mexico.
[229429]
Customer service received a call from user's mother who stated the pt slipped through the rails on a bariatric bed causing unconsciousness and bruises.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1525712-2002-00049 |
| MDR Report Key | 396312 |
| Report Source | 04 |
| Date Received | 2002-05-10 |
| Date of Report | 2002-05-07 |
| Date of Event | 2002-04-17 |
| Date Mfgr Received | 2002-04-24 |
| Date Added to Maude | 2002-05-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| 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 | 4403263115 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INVACARE BEDS |
| Generic Name | * |
| Product Code | FNK |
| Date Received | 2002-05-10 |
| Model Number | UNKBEDRAIL |
| Catalog Number | * |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | I |
| Device Sequence No | 1 |
| Device Event Key | 385340 |
| Manufacturer | INVAMEX - INVACARE MEXICO |
| Manufacturer Address | CARRETERA REYNOSA-MATAMROS KM#1 REYNOSA TAMAULIPAS MX ZY 88500 |
| Baseline Brand Name | INVACARE BEDS |
| Baseline Generic Name | * |
| Baseline Model No | UNKBEDRAIL |
| Baseline Catalog No | * |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-05-10 |