MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-07-10 for INCOURAGE SYSTEM ICS-1M-US-A 500055-000 manufactured by Respiratory Technologies Inc..
[113517913]
Review of records showed no other similar reports.
Patient Sequence No: 1, Text Type: N, H10
[113517914]
Patient reported breast pain, which was diagnosed as mastitis. Attending physician could not determine if vest therapy was the cause of the condition. The manufacturer believes they will be unable to gather additional information or complete an evaluation of the device. The manufacturer is submitting a final report at this time. If pertinent information becomes available to the manufacturer at a later date, an addendum to this final report will be filed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004961434-2018-00001 |
| MDR Report Key | 7673238 |
| Report Source | CONSUMER |
| Date Received | 2018-07-10 |
| Date of Report | 2018-06-12 |
| Date of Event | 2018-05-15 |
| Date Mfgr Received | 2018-06-12 |
| Device Manufacturer Date | 2018-01-12 |
| Date Added to Maude | 2018-07-10 |
| 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 | MR. DAVID WESTLIN |
| Manufacturer Street | 2896 CENTRE POINTE DRIVE |
| Manufacturer City | ST PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6513483837 |
| Manufacturer G1 | RESPIRATORY TECHNOLOGIES INC. |
| Manufacturer Street | 2896 CENTRE POINTE DRIVE |
| Manufacturer City | ST PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55113 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INCOURAGE SYSTEM |
| Generic Name | PULSATING VEST THERAPY |
| Product Code | BYI |
| Date Received | 2018-07-10 |
| Model Number | ICS-1M-US-A |
| Catalog Number | 500055-000 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRATORY TECHNOLOGIES INC. |
| Manufacturer Address | 2896 CENTRE POINTE DRIVE ST PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-07-10 |