MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-02-24 for EXPRESS COMPRESSION SYSTEM * 9529 manufactured by Tyco Healthcare/kendall.
[20761021]
It was reported to tyco healthcare/kednall that a customer had a problem with a compression system. The customer states "patient had bruising on leg while wearing sleeves. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017072-2005-00002 |
| MDR Report Key | 578158 |
| Report Source | 07 |
| Date Received | 2005-02-24 |
| Date of Report | 2005-02-23 |
| Date of Event | 2005-02-18 |
| Report Date | 2005-02-23 |
| Date Mfgr Received | 2005-02-18 |
| Date Added to Maude | 2005-03-07 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ESIE CABRAL |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5082618488 |
| Manufacturer G1 | SENECA |
| Manufacturer Street | 1448 BLUE RIDGE BOULEVARD |
| Manufacturer City | SENECA SC 29672 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29672 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPRESS COMPRESSION SYSTEM |
| Generic Name | COMPRESSION SYSTEM |
| Product Code | DWL |
| Date Received | 2005-02-24 |
| Model Number | * |
| Catalog Number | 9529 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 568007 |
| Manufacturer | TYCO HEALTHCARE/KENDALL |
| Manufacturer Address | 15 HAMPSHIRE ST MANSFIELD MA 02048 US |
| Baseline Brand Name | EXPRESS COMPRESSION SYSTEM |
| Baseline Generic Name | COMPRESSION SYSTEM |
| Baseline Model No | * |
| Baseline Catalog No | 9529 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-02-24 |