MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-05-15 for PERM-A-CATH NI manufactured by Unknown.
[14651]
Catheter was removed since it wasn't working well. Physician expected better operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 22261 |
| MDR Report Key | 22261 |
| Date Received | 1995-05-15 |
| Date of Report | 1995-05-15 |
| Date of Event | 1995-04-28 |
| Date Facility Aware | 1995-04-28 |
| Report Date | 1995-05-15 |
| Date Reported to FDA | 1995-05-15 |
| Date Added to Maude | 1995-06-07 |
| 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 | PERM-A-CATH |
| Generic Name | PERM-A-CATH |
| Product Code | FIQ |
| Date Received | 1995-05-15 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 22368 |
| Manufacturer | UNKNOWN |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 1995-05-15 |