MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for SINGLE LUMEN HEMED CATHETER manufactured by Gish Biomedical Inc..
[6322]
Patient had central line placed on 8/25/92 and 4/12/93 for infected right ankle with secondary chronic osteomyelitis. On 4/14/94, patient had surgery to remove the "velcro cuff" from both catheters. Culture from hickman cath site on 3/20/94 showed heavy growth of staphylococcus coagulase negative.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 17687 |
| MDR Report Key | 17687 |
| Date Received | 1994-07-29 |
| Date of Report | 1994-04-22 |
| Date of Event | 1994-04-11 |
| Date Facility Aware | 1994-04-14 |
| Report Date | 1994-04-22 |
| Date Added to Maude | 1994-11-15 |
| 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 | SINGLE LUMEN HEMED CATHETER |
| Generic Name | HICKMAN CATHETER |
| Product Code | FEF |
| Date Received | 1994-07-29 |
| Lot Number | 119277 (8-25-92 CATHETER) |
| ID Number | UNKNOWN FOR 4/12/93 CATHETER |
| Device Availability | N |
| Device Age | 24 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 17604 |
| Manufacturer | GISH BIOMEDICAL INC. |
| Manufacturer Address | 2681 KELVIN AVENUE IRVINE CA 927145821 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |