MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-11-29 for INCOURAGE SYSTEM manufactured by Respiratory Technologies Inc..
[128801856]
Patient reported persistent abdominal discomfort. Ct scan noted large abdominal rectus sheath hematoma. Attending physician stated the patient was very frail and believes that the combination of blood thinners and the vibrations from the vest may have been the contributing causes of the hematoma. Patient had no long term negative consequences from the hematoma and it is left to resolve on its own.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004961434-2018-00003 |
| MDR Report Key | 8116948 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-11-29 |
| Date of Report | 2018-11-04 |
| Date of Event | 2018-11-03 |
| Date Mfgr Received | 2018-11-04 |
| Date Added to Maude | 2018-11-29 |
| 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 | 2018-11-29 |
| Operator | HEALTH PROFESSIONAL |
| 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. Hospitalization | 2018-11-29 |