MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2019-09-20 for FLEXITOUCH SYSTEM PD32-U manufactured by Tactile Systems Technology Inc.dba Tactile Medical.
| Report Number | 3004183730-2019-00002 |
| MDR Report Key | 9099849 |
| Report Source | CONSUMER |
| Date Received | 2019-09-20 |
| Date of Report | 2019-08-20 |
| Date of Event | 2017-11-15 |
| Date Mfgr Received | 2019-08-20 |
| Date Added to Maude | 2019-09-20 |
| 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 | BRETT DEMCHUK |
| Manufacturer Street | 151 5TH AVENUE NW |
| Manufacturer City | NEW BRIGHTON MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 6123555135 |
| Manufacturer G1 | TACTILE SYSTEMS TECHNOLOGY INC DBA TACTILE MEDICAL |
| Manufacturer Street | 151 5TH AVENUE NW |
| Manufacturer City | NEW BRIGHTON MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXITOUCH SYSTEM |
| Generic Name | PNEUMATIC COMPRESSION DEVICE |
| Product Code | JOW |
| Date Received | 2019-09-20 |
| Model Number | PD32-U |
| Catalog Number | PD32-U |
| Lot Number | 11145, 17023, 113340 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TACTILE SYSTEMS TECHNOLOGY INC.DBA TACTILE MEDICAL |
| Manufacturer Address | 151 5TH AVENUE NW NEW BRIGHTON MN 55112 US 55112 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-09-20 |