MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,07 report with the FDA on 2000-08-24 for FLOWTRON AC550-GARMENT UNKNOWN manufactured by Huntleigh Healthcare, Inc..
[21257655]
On 7/27/00 initial rptr rec'd report from hospital orthopedist that alleged that two patients experienced complications while on the huntleigh external pneumatic compression system: one (1) pulmonary embolism and one (1) peroneal nerve palsy.
Patient Sequence No: 1, Text Type: D, B5
[21326276]
On 7/27/00 initial rptr rec'd report from hosp orthopedist that alleged that two patients experienced complications while on the huntleigh external penumatic compression system: one (1) pulmonary embolism and one (1) personeal nerve palsy.
Patient Sequence No: 2, Text Type: D, B5
| Report Number | 2431480-2000-00410 |
| MDR Report Key | 292095 |
| Report Source | 00,07 |
| Date Received | 2000-08-24 |
| Date of Report | 2000-08-24 |
| Date Mfgr Received | 2000-07-28 |
| Date Added to Maude | 2000-08-25 |
| 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 | AUDREY WITKO, V.P. |
| Manufacturer Street | 40 CHRISTOPHER WAY |
| Manufacturer City | EATONTOWN NJ 07724 |
| Manufacturer Country | US |
| Manufacturer Postal | 07724 |
| Manufacturer Phone | 8002237218 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOWTRON |
| Generic Name | EXTERNAL PNEUMATIC COMPRESSION SYSTEM |
| Product Code | JFA |
| Date Received | 2000-08-24 |
| Model Number | AC550-GARMENT UNKNOWN |
| Catalog Number | AC550-GARMENT UNKNOWN |
| Lot Number | 510(K)#: K961166 |
| ID Number | 2431480 EST. REG. NUMBER |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 282712 |
| Manufacturer | HUNTLEIGH HEALTHCARE, INC. |
| Manufacturer Address | 40 CHRISTOPHER WAY EATONTOWN NJ 07724 US |
| Baseline Brand Name | FLOWTRON |
| Baseline Generic Name | EXTERNAL PNEUMATIC COMPRESSION SYSTEM |
| Baseline Model No | AC550-GARMENT U |
| Baseline Catalog No | AC550-GARMENT UNKNOWN |
| Baseline ID | 2431480 EXT. RE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-08-24 | |
| 2 | 0 | 2000-08-24 |