MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-06-30 for PERITONEAL DIALYSIS CATHETER SNMZ LEFT manufactured by Accurate Surgical Instr. Co..
[10018]
Pt suffering from peritonitis. In considerable pain.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 16454 |
| MDR Report Key | 16454 |
| Date Received | 1994-06-30 |
| Date of Report | 1994-06-30 |
| Date of Event | 1994-06-25 |
| Date Facility Aware | 1994-06-25 |
| Report Date | 1994-06-30 |
| Date Reported to FDA | 1994-06-30 |
| Date Added to Maude | 1994-09-28 |
| 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 | PERITONEAL DIALYSIS CATHETER |
| Generic Name | PERITONEAL DIALYSIS CATHETER |
| Product Code | FKO |
| Date Received | 1994-06-30 |
| Catalog Number | SNMZ LEFT |
| Lot Number | HX99-82-70 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 MO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 16387 |
| Manufacturer | ACCURATE SURGICAL INSTR. CO. |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-06-30 |