MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-01 for DENVER PERITONEO - VENOUS SHUNT UNKNOWN 42-4000 manufactured by J & J Codman.
[704]
Patient underwen denver shunt placement on 3/12/92. The denver shunt had to be removed and replaced on 3/27/92 due to malfunctiondevice labeled for single use. Patient medical status prior to event: fair condition. 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: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: none or unknown. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 879 |
| MDR Report Key | 879 |
| Date Received | 1992-07-01 |
| Date of Report | 1992-06-15 |
| Date of Event | 1992-03-12 |
| Date Facility Aware | 1992-03-27 |
| Report Date | 1992-06-15 |
| Date Reported to FDA | 1992-06-15 |
| Date Reported to Mfgr | 1992-06-12 |
| Date Added to Maude | 1992-07-13 |
| 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 | DENVER PERITONEO - VENOUS SHUNT |
| Generic Name | UNKNOWN |
| Product Code | FIQ |
| Date Received | 1992-07-01 |
| Model Number | UNKNOWN |
| Catalog Number | 42-4000 |
| Lot Number | JG 906 |
| ID Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | N |
| Device Age | 01-DEC-90 |
| Implant Flag | Y |
| Device Sequence No | 1 |
| Device Event Key | 836 |
| Manufacturer | J & J CODMAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-07-01 |