MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-09-30 for HMP PORT HMP 2112 manufactured by Hdc Corporation.
[13732]
The septum from the hmp dislodged from the portal body. The surgeon replaced the port so that chemotherapy treatments could continue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1056436-1994-00016 |
| MDR Report Key | 19550 |
| Date Received | 1994-09-30 |
| Date of Report | 1994-09-08 |
| Date of Event | 1994-09-04 |
| Date Added to Maude | 1995-02-09 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | HMP PORT |
| Generic Name | IMPLANTABLE DRUG PORT |
| Product Code | MHC |
| Date Received | 1994-09-30 |
| Returned To Mfg | 1994-09-08 |
| Model Number | HMP 2112 |
| Device Availability | R |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 19455 |
| Manufacturer | HDC CORPORATION |
| Manufacturer Address | 2109 O'TOOLE AVENUE SAN JOSE CA 95131 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-09-30 |