MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2011-01-18 for MARLOW BALLOON CANNULA, 5MM ML0500D * manufactured by Cooper Surgical.
[20091933]
Balloon failed on product marlow 5mm balloon canula - balloon popped.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1976191 |
| MDR Report Key | 1976191 |
| Date Received | 2011-01-18 |
| Date of Report | 2011-01-18 |
| Date of Event | 2011-01-14 |
| Report Date | 2011-01-18 |
| Date Reported to FDA | 2011-01-18 |
| Date Added to Maude | 2011-02-01 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MARLOW BALLOON CANNULA, 5MM |
| Generic Name | 5MM BALLOON CANULA |
| Product Code | MFD |
| Date Received | 2011-01-18 |
| Model Number | ML0500D |
| Catalog Number | * |
| Lot Number | 060702 |
| ID Number | * |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPER SURGICAL |
| Manufacturer Address | 95 CORPORATE DRIVE TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-18 |