MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-07-06 for QUICK C DOUBLE CONTRAST BARIUM ENEMA TUBE manufactured by Mmi.
[21962461]
Pt developed the following sympoms during and immediately after barium enema examination: runny nose, sneezing, cough, chest tightness, itching, burning eyes, erythema, tingling around mouth and upper extremities, nausea and vomiting. Product packaging did not readily identify latex component of the retention cuff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 23954 |
| MDR Report Key | 23954 |
| Date Received | 1995-07-06 |
| Date of Report | 1995-01-25 |
| Date of Event | 1995-01-10 |
| Date Facility Aware | 1995-01-10 |
| Report Date | 1995-01-26 |
| Date Reported to Mfgr | 1995-01-26 |
| Date Added to Maude | 1995-08-02 |
| 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 | QUICK C DOUBLE CONTRAST BARIUM ENEMA TUBE |
| Generic Name | BARIUM ENEMA TUBE |
| Product Code | FGD |
| Date Received | 1995-07-06 |
| Lot Number | B-305-57-1 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 24288 |
| Manufacturer | MMI |
| Manufacturer Address | S. FIELD MI 48075 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-07-06 |