MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-10-11 for SCD EXPRESS SLEEVE K/L MEDIUM 9529 manufactured by Tyco Kendall Healthcare.
[16278324]
A customer had a problem with the scd express sleeve k/l medium. According to the customer while using the scd sleeve bruising was observed on the front and sides of the mid-lower limbs and below the ankle bone.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1017072-2005-00009 |
| MDR Report Key | 640272 |
| Report Source | 00 |
| Date Received | 2005-10-11 |
| Date of Report | 2005-09-09 |
| Date of Event | 2005-09-05 |
| Date Mfgr Received | 2005-09-09 |
| Date Added to Maude | 2005-10-13 |
| 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 | 0 |
| Manufacturer Contact | RAYMOND GAGNON RN |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | * |
| Manufacturer Country | * |
| Manufacturer Phone | 2616387 |
| Manufacturer G1 | TYCO / KENDALL HEALTHCARE |
| 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 | SCD EXPRESS SLEEVE K/L MEDIUM |
| Generic Name | KENDALL HEALTHCARE SCD SLEEVES |
| Product Code | DWL |
| Date Received | 2005-10-11 |
| Model Number | 9529 |
| Catalog Number | 9529 |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 629783 |
| Manufacturer | TYCO KENDALL HEALTHCARE |
| Manufacturer Address | 1448 BLUE RIDGE BLVD. SENECA SC 29672 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 | 2005-10-11 |