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 |