MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-30 for CRE? PULMONARY M00550350 5035 manufactured by .
[98680591]
For the 5 events reported under exemption number (b)(4), 3 complaint devices were returned and 2 complaint devices were disposed. 2 events were found to have a root cause of handling, investigation is still in place for 1 event.
Patient Sequence No: 1, Text Type: N, H10
[98680592]
The manufacturer report is being sent as a requirement under summary reporting exemption approval number - (b)(4) for product code kti. This report covers 5 reported events of balloons bursts/pinholes/leaks. Of the events, 1 patient was male. The known patients' ages ranged from 39 years to 56 years. The known patients' weights ranged from (b)(6). All other demographic information is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-00225 |
| MDR Report Key | 7228504 |
| Date Received | 2018-01-30 |
| Date of Report | 2018-01-01 |
| Date Added to Maude | 2018-01-30 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | EMP. NANCY CUTINO |
| Manufacturer Street | 100 BOSTON SCIENTIFIC WAY |
| Manufacturer City | MARLBOROUGH MA 01752 |
| Manufacturer Country | US |
| Manufacturer Postal | 01752 |
| Manufacturer Phone | 5086834000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CRE? PULMONARY |
| Generic Name | BRONCHOSCOPE ACCESSORY |
| Product Code | KTI |
| Date Received | 2018-01-30 |
| Model Number | M00550350 |
| Catalog Number | 5035 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-30 |