MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-03-05 for UNKNOWN manufactured by Unknown.
[193]
Patient admitted to have cuff of capd catheter debrided;has infection around exit site of catheter. Cuff to be debrided in attempt to salvage catheter. Patient has been on chronic antibodics in attempt to control infection. Tip of cuff is visable through the skindevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: no data. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: use of all similar devices stopped temporarily. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 271 |
| MDR Report Key | 271 |
| Date Received | 1992-03-05 |
| Date of Report | 1992-02-24 |
| Date of Event | 1992-01-28 |
| Date Facility Aware | 1992-02-13 |
| Report Date | 1992-02-24 |
| Date Reported to FDA | 1992-02-24 |
| Date Added to Maude | 1992-04-14 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | CAPD CATHETER |
| Product Code | EZK |
| Date Received | 1992-03-05 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 267 |
| Manufacturer | UNKNOWN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-03-05 |