MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-03-01 for CHEMO-SITE PRODUCT # 350297 manufactured by Device Labs.
[11228]
68 yo patient had implantation of a chemoport as angioaccess for iv chemotherapy in february, 94. Functioning well until recently when irrigation produced subcutaneous swelling below left clavicle. Contrast studies through port showed two separate areas of extravasation. To or for revision of port; catheter found to be sheared off 5/20/94 removal of sheared off portion of catheter
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 20555 |
| MDR Report Key | 20555 |
| Date Received | 1995-03-01 |
| Date of Report | 1994-05-23 |
| Date of Event | 1994-05-09 |
| Date Facility Aware | 1994-05-19 |
| Report Date | 1994-05-23 |
| Date Reported to Mfgr | 1994-05-23 |
| Date Added to Maude | 1995-03-24 |
| 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 |
| Reporter Occupation | ATTORNEY |
| 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 | CHEMO-SITE |
| Generic Name | PORTA-CATH |
| Product Code | LLD |
| Date Received | 1995-03-01 |
| Model Number | PRODUCT # 350297 |
| Lot Number | 9306 |
| ID Number | REORDER # 120044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 3 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 20439 |
| Manufacturer | DEVICE LABS |
| Manufacturer Address | 3 INDUSTRIAL PARK RD. MEDWAY MA 02053 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1995-03-01 |