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 |