MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-09-05 for EZ-EM 8816 8816-CATALOG # FOR MFR manufactured by Ez-em, Inc..
[78781]
July 8, 1997 77 yr female for be as outpatient was admitted after sustaining a respiratory arrest in the radiology dept during a barium enema. Pt had h/o cva and was on coumadin for a-fib. Had flexible sigmoidoscopy in office with no problems. After insertion of rectal tube pt had problems with hypotension and bradycardia then sustained respiratory arrest. Drugs given during code in radiology: fluids, epinephrine, atropine, and dopamine. The pt was transported to ccu where resuscitation continued. Pt was noted to have a large amount of vaginal bleeding in icu. A surgery consult was obtained. Surgical consult felt there may have been a latex allergy and avoided the use of enema balloon. No sign of fistula. There was noted to be barium in the vagina. 7/9/97 pt had several apneic episodes progressing to respiratory arrest, pt expired at 6 pm; family did not want autopsy. No intubation was done at pt/family request.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012034 |
| MDR Report Key | 117740 |
| Date Received | 1997-09-05 |
| Date of Report | 1997-08-08 |
| Date of Event | 1997-07-08 |
| Date Added to Maude | 1997-09-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EZ-EM |
| Generic Name | BARIUM ENEMA TIP |
| Product Code | FCD |
| Date Received | 1997-09-05 |
| Model Number | 8816 |
| Catalog Number | 8816-CATALOG # FOR MFR |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 115475 |
| Manufacturer | EZ-EM, INC. |
| Manufacturer Address | 717 MAIN ST WESTBURY NY 11590 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 1997-09-05 |