MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-27 for PORT-A-CATH 1969378 manufactured by Allergan/apollo Endosurgery Inc..
[87728878]
Md unable to access port in office. Patient returned to operating room and device found to have flipped 90 degrees, becoming inaccessible.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5072495 |
| MDR Report Key | 6897746 |
| Date Received | 2017-09-27 |
| Date of Report | 2017-09-25 |
| Date of Event | 2017-09-21 |
| Date Added to Maude | 2017-09-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PORT-A-CATH |
| Generic Name | LAPAROSCOPIC BAND SYSTEM ACCESS |
| Product Code | LNY |
| Date Received | 2017-09-27 |
| Model Number | 1969378 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN/APOLLO ENDOSURGERY INC. |
| Manufacturer Address | SANTA BARBARA CA 93111 US 93111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-09-27 |