MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-21 for CONTOUR 5000 UNK UNTRACEABLE UNK manufactured by R & R Industries, Inc..
[384848]
Employer sent employee out on a delivery employer said (implied back support belt is safety equipment) and mandatory to wear. Device collapsed on employee when lifting two cases of antifreeze that were double taped together for shipping back support belt failed came loose did not stablize employer and manufacturer failed to warn of impending dangers of such device. Employee received grevious injury to lower back at l3-l4 l4-l5 l5 -s1 which gave a permanent injury. [note** medical device is sold through a industrial safety catalog] employer knew about device as not being safety equipment. Employer implied back support belt as being safety equipment and mandatory to wear product is untraceable as their is no skew on product or model# on such device or catalog# on such device no expiration on such device. Employer and manufacturer failed to warn of impending danger of such device. Employer and manufacturer failed to label such device as medical equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034112 |
| MDR Report Key | 564028 |
| Date Received | 2004-11-21 |
| Date of Report | 2004-11-21 |
| Date of Event | 2001-03-29 |
| Date Added to Maude | 2005-01-10 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONTOUR 5000 |
| Generic Name | LUMBAR ABDOMINAL BACK SUPPORT BELT |
| Product Code | IQE |
| Date Received | 2004-11-21 |
| Model Number | UNK UNTRACEABLE |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Device Expiration Date | 2001-01-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 553762 |
| Manufacturer | R & R INDUSTRIES, INC. |
| Manufacturer Address | 1000 CALLE CORDILLERA SAN CLEMENTIE CA 92673 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Deathisabilit | 2004-11-21 |