MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-06-22 for EZ AC AND SUPER XL ENEMA KIT SAME L186,L178,8925 manufactured by E-z-em, Inc..
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Patient had barium enema w/air-became flushed & stuffy nose. Hard to swallow-up to pr-nose runny. Then cough-hives wheezy visited by dr. Epi. 35c & benadryl 50 mg iv - ns 500 back open uss bp 130/72 p 96device labeled for single use. Patient medical status prior to event: unknown. 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. Device was evaluated after the event. Method of evaluation: a device from same lot was evaluated, other. Results of evaluation: none or unknown, anticipated adverse reaction - short term. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 759 |
| MDR Report Key | 759 |
| Date Received | 1992-06-22 |
| Date of Report | 1992-06-05 |
| Date of Event | 1992-05-27 |
| Date Facility Aware | 1992-05-27 |
| Report Date | 1992-06-05 |
| Date Reported to FDA | 1992-06-05 |
| Date Reported to Mfgr | 1992-05-27 |
| Date Added to Maude | 1992-06-23 |
| 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 | EZ AC AND SUPER XL ENEMA KIT |
| Generic Name | BARIUM ENEMA PRODUCTS |
| Product Code | FGD |
| Date Received | 1992-06-22 |
| Model Number | SAME |
| Catalog Number | L186,L178,8925 |
| Lot Number | (EZAC LE2031)SUPER XL05228925 |
| ID Number | N/A |
| Device Expiration Date | 1995-04-01 |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 744 |
| Manufacturer | E-Z-EM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1992-06-22 |