MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-08 for DYND70104H manufactured by Medline Industries Inc..
[132485579]
Manufacturer was notified via medwatch ((b)(4)) of an incident that occurred at an end-user facility. It was reported that the patient was undergoing an exploratory laparotomy on (b)(6) 2018 due to a bowel obstruction when two enema caps were noticed inside the patient. The facility reported that the patient received two enemas on (b)(6) 2018. One enema was reportedly given by a facility nurse and one enema given by a student nurse/instructor. The facility reported that the caps were not noticed as missing during either of the enema administrations so the facility is unsure of the actual event date that resulted in the enema caps being left inside the patient. There was no additional medical intervention reported and the patient is reportedly doing well. A sample is not available to be returned for evaluation and a root cause could not be determined. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional relevant information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10
[132485580]
It was reported that a patient was undergoing an exploratory laparotomy due to a bowel obstruction when two enema caps were noticed inside the patient from a previous enema and removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00150 |
| MDR Report Key | 8226845 |
| Date Received | 2019-01-08 |
| Date of Report | 2019-01-08 |
| Date of Event | 2018-02-08 |
| Date Mfgr Received | 2018-12-27 |
| Date Added to Maude | 2019-01-08 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Generic Name | SET,BUCKET,ENEMA |
| Product Code | FCE |
| Date Received | 2019-01-08 |
| Catalog Number | DYND70104H |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-08 |