MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for MEDI-PAK CLEANSING ENEMA SET 159545 manufactured by General Medical Corporation.
[6019]
Student nurse inserted enema catheter approximately 2 1/2 inches. The catheter cap was not removed prior to insertion. The cap remained in the rectum when the catheter was withdrawn. The patient was unable to pass the cap. The patient had a decompression colonoscopy and the cap was removed without problems. The patient would have had the decompression colonscopy even if this event had not occurred (due to medical condition). Device 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 not used as labeled/indended. Device was not evaluated after the event. Method of evaluation: no data. Results of evaluation: no data. Conclusion: no data. Certainty of device as cause of or contributor to event: no. Corrective actions: user education provided. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9090 |
| MDR Report Key | 9090 |
| Date Received | 1994-07-29 |
| 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 Mfgr | 1994-04-08 |
| Date Added to Maude | 1994-11-28 |
| 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 | 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 | MEDI-PAK CLEANSING ENEMA SET |
| Generic Name | NA |
| Product Code | FCE |
| Date Received | 1994-07-29 |
| Model Number | NA |
| Catalog Number | 159545 |
| Lot Number | 4060-493 |
| ID Number | 54-150 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Device Age | 01-FEB-94 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 8750 |
| Manufacturer | GENERAL MEDICAL CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-07-29 |