MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-26 for CRE? PULMONARY M00550310 5031 manufactured by .
[91187680]
For the 1 event reported under exemption number (b)(4), the product has been returned but analysis has not yet been completed.
Patient Sequence No: 1, Text Type: N, H10
[91187681]
The manufacturer report is being sent as a requirement under summary reporting exemption approval number - (b)(4) for product code kti. This report summarizes 1 reported event of balloon leak. It was reported that the patient was over 18 years of age. All other demographic information is unknown.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3005099803-2017-03248 |
MDR Report Key | 6980445 |
Date Received | 2017-10-26 |
Date of Report | 2017-10-01 |
Date Added to Maude | 2017-10-26 |
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 | 2017-10-26 |
Model Number | M00550310 |
Catalog Number | 5031 |
Device Availability | * |
Device Eval'ed by Mfgr | Y |
Device Sequence No | 1 |
Device Event Key | 0 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2017-10-26 |