MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-15 for DYND70100 manufactured by Medline.
[127231327]
While admitted to the facility, a patient experienced constipation. A soap suds enema is ordered. A boxed enema set is utilized for setup and use. Later in the day the patient is discharged to home. The patient's family called the facility (much later) to share that while at home and providing peri-care to the former patient, a blue object is noted to be protruding from her anus. The blue item is pulled out by family and they notified the facility with photos of the item. The item is thought to be (by family) the blue tip protector, which covers the pre-lubricated tubing. Manufacturer notified by patient's family and facility. No response. Family express wishes to make improvements to the product to prevent such an issue from happening in the future. The device and photos are available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8073077 |
| MDR Report Key | 8073077 |
| Date Received | 2018-11-15 |
| Date of Report | 2018-11-02 |
| Date of Event | 2018-07-11 |
| Report Date | 2018-11-02 |
| Date Reported to FDA | 2018-11-02 |
| Date Reported to Mfgr | 2018-11-15 |
| Date Added to Maude | 2018-11-15 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | CLEANSING ENEMA SET, BOXED |
| Product Code | FCE |
| Date Received | 2018-11-15 |
| Catalog Number | DYND70100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | 1204 TOWNLINE RD 1 MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-15 |