MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-02-20 for M.R.I.? LOW-PROFILE IMPLANTABLE PORT 3465 manufactured by Bard Access Systems, Inc..
[5513237]
Implantable port was removed from patient due to leak. Once removed, the surgeon noted that this port has a hole on the back side allowing fluid to leak.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4538913 |
| MDR Report Key | 4538913 |
| Date Received | 2015-02-20 |
| Date of Report | 2015-02-20 |
| Date of Event | 2015-01-28 |
| Report Date | 2015-02-20 |
| Date Reported to FDA | 2015-02-20 |
| Date Reported to Mfgr | 2015-02-24 |
| Date Added to Maude | 2015-02-24 |
| 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 | M.R.I.? LOW-PROFILE IMPLANTABLE PORT |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LKG |
| Date Received | 2015-02-20 |
| Model Number | M.R.I.? LOW-PROFILE |
| Catalog Number | 3465 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 2 DA |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS, INC. |
| Manufacturer Address | 605 NORTH 5600 WEST SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-02-20 |