MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-26 for CRE? PULMONARY M00550350 5035 manufactured by .
[106839743]
For the 4 events reported under exemption number (b)(4), 3 complaint devices were returned, and 1 complaint device was disposed. One (1) event was found to have a root cause of operational context, and 1 event was found to have a root cause of handling. Investigation is still in place for 1 event. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[106839744]
The manufacturer report is being sent as a requirement under summary reporting exemption approval number (b)(4) for product code kti. This report covers 4 reported events of balloons hole/leak/tears. Of the events, 2 patients were female and 1 was male. The known patients' ages ranged from 55 years to 68 years. The known patients' weights ranged from 43 kg to 70 kg. All other demographic information is unknown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005099803-2018-01402 |
| MDR Report Key | 7464191 |
| Date Received | 2018-04-26 |
| Date of Report | 2018-03-31 |
| Date Added to Maude | 2018-04-26 |
| 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 | 2018-04-26 |
| 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 | 2018-04-26 |