MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-08 for PORT TITANIUM WITH GROSHONG manufactured by Davol, Inc..
[19145648]
The pt was admitted for outpatient surgery to remove the port-a-cath. The catheter had fragmented and was retrieved in april but the pt was not stable at the time for surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 23919 |
| MDR Report Key | 23919 |
| Date Received | 1995-07-08 |
| Date of Report | 1995-06-06 |
| Date of Event | 1995-05-26 |
| Date Facility Aware | 1995-05-26 |
| Report Date | 1995-06-06 |
| Date Added to Maude | 1995-08-01 |
| 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 | PORT TITANIUM WITH GROSHONG |
| Generic Name | PORT A CATH |
| Product Code | LJK |
| Date Received | 1995-07-08 |
| ID Number | 9504 |
| Device Availability | Y |
| Device Age | 1 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 24253 |
| Manufacturer | DAVOL, INC. |
| Manufacturer Address | CRANSTON RI 02920 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1995-07-08 |