MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-04-22 for MEDI-PAK CLEANSING ENEMA SET 159545 manufactured by General Medical Co..
[17178618]
General medical corp. Received a response from their manufacturer, plasco, inc concerning this ufr report: as the manufacturer of this device, on may 18, 1994 we also submitted an mdr for this event. Our investigation classified this event as a user error with no corrective action required. The printed directions for use on the carton require removal of the sheath from prelubricated tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8144 |
| MDR Report Key | 8144 |
| Date Received | 1994-04-22 |
| Date of Report | 1994-04-08 |
| Date of Event | 1994-03-29 |
| Date Facility Aware | 1994-03-29 |
| Report Date | 1994-04-08 |
| Date Reported to FDA | 1994-04-08 |
| Date Reported to Mfgr | 1994-04-08 |
| Date Added to Maude | 1994-07-19 |
| 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 | MEDI-PAK CLEANSING ENEMA SET |
| Generic Name | ENEMA SET |
| Product Code | FCE |
| Date Received | 1994-04-22 |
| Model Number | NA |
| Catalog Number | 159545 |
| Lot Number | 4060-493 |
| ID Number | 54-150 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 7819 |
| Manufacturer | GENERAL MEDICAL CO. |
| Manufacturer Address | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-04-22 |