MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-24 for THE INCOURAGE SYSTEM ICS-1M-US manufactured by Respiratory Technologies, Inc..
[92932096]
At the time of this report, the device has not been returned for analysis. Without the return of the product, no conclusions can be made regarding the event. If additional information is received, a supplemental report will be submitted. Multiple attempts have been made to obtain additional information regarding patient information, patient outcome, and whether patient received additional intervention. At this time no further information has been made available to respiratory technologies. If additional information is received a supplemental report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[92932097]
Respiratory technologies received information during routine follow-up that a patient experienced a rupture of one of the patient's saline breast implants following the use of the incourage airway clearance therapy system. There have been no adverse events reported by the patient in the months since the event occurred. The patient had consulted with her physician and the physician stated there are no risks due to the rupture. The incourage device has not yet been returned for analysis, but product return is expected.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004961434-2017-00001 |
| MDR Report Key | 7057949 |
| Date Received | 2017-11-24 |
| Date of Report | 2017-10-26 |
| Date of Event | 2017-07-01 |
| Date Mfgr Received | 2017-10-26 |
| Device Manufacturer Date | 2016-09-27 |
| Date Added to Maude | 2017-11-24 |
| 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 | SAINT PAUL MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6513798999 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | THE INCOURAGE SYSTEM |
| Generic Name | AIRWAY CLEARANCE VEST THERAPY |
| Product Code | BYI |
| Date Received | 2017-11-24 |
| Model Number | ICS-1M-US |
| Catalog Number | ICS-1M-US |
| 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 DRIVER SAINT PAUL MN 55113 US 55113 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-11-24 |