MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-02-15 for MILLER AIR TIP (WITHIN THE SUPER XL ENEMA BAG SYSTEM) N/A manufactured by E-z-em, Inc..
[1292]
Apparent allergic reaction to latex enema tip during afterfilms on barium enema. Tip had been inserted 20-30 minutes when patient experienced hives and itching. This was out-patient with no significant serious illiness; no explanation for reaction than above given. Benadryl 50 mgm im administtered and raction resolveddevice labeled for single use. Patient medical status prior to event: satisfactory 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. Invalid data - regarding whether event presents imminent hazard. Device used as labeled/intended. 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: invalid data. Corrective actions: no data. The device was destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2419 |
| MDR Report Key | 2419 |
| Date Received | 1993-02-15 |
| Date of Report | 1992-12-29 |
| Date of Event | 1992-12-28 |
| Date Facility Aware | 1992-12-28 |
| Report Date | 1992-12-29 |
| Date Added to Maude | 1993-03-08 |
| 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 | MILLER AIR TIP (WITHIN THE SUPER XL ENEMA BAG SYSTEM) |
| Generic Name | LATEX ENEMA TIP |
| Product Code | FCD |
| Date Received | 1993-02-15 |
| Model Number | N/A |
| Catalog Number | N/A |
| Lot Number | 19228925 AND 15428925 |
| ID Number | N/A |
| Operator | OTHER HEALTH CARE PROFESSIONAL |
| Device Availability | N |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 2245 |
| Manufacturer | E-Z-EM, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1993-02-15 |