MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-01-14 for DISPOSABLE PHOSPHATE ENEMA 20306-010 manufactured by Chester Laboratories.
[88222]
The nurse was administering the enema when the pt became diaphoretic and complained of lower abdominal pain at which point the nurse stopped administering the enema. He expelled the contents of the enema and there was a small amount of blood expelled as well. The doctor performed a sigmoidoscopy and observed a rectal tear. The pt was hospitalized until 12/21/97 and received antibiotics and observation. During his hospitalization he experienced an elevated wbc, nausea and vomiting, and a low grade temperature. He has had a follow-up doctors visit post hospitalization and no add'l treatment was needed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6000008-1998-00002 |
| MDR Report Key | 143640 |
| Date Received | 1998-01-14 |
| Date of Report | 1998-01-14 |
| Date of Event | 1997-12-19 |
| Date Facility Aware | 1998-01-08 |
| Report Date | 1998-01-14 |
| Date Reported to FDA | 1998-01-14 |
| Date Reported to Mfgr | 1998-01-08 |
| Date Added to Maude | 1998-01-15 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | DISPOSABLE PHOSPHATE ENEMA |
| Generic Name | DISPOSABLE PHOSPHATE ENEMA |
| Product Code | FCE |
| Date Received | 1998-01-14 |
| Model Number | 20306-010 |
| Catalog Number | 20306-010 |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 140101 |
| Manufacturer | CHESTER LABORATORIES |
| Manufacturer Address | 1900 SECTION RD STE A CINCINNATI OH 45237 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1998-01-14 |