SURGICAL DRAIN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-05 for SURGICAL DRAIN manufactured by Unk.

Event Text Entries

[101711720] A (b)(6) year old male with degenerative joint disease, underwent left total knee replacement. Post op orders were entered for a surgical drain, including to remove the drain the next day, and the patient was discharged on day 2. Three days later the patient presented to the emergency department for bleeding from the incision. Work up did not identify any acute problems and the patient was discharged. At an ortho office visit, an x-ray identified a retained foreign body and the patient returned for surgery to remove a segment of a surgical drain. The patient was discharged to home later that day. Event investigated by clinical managers and referred to nursing peer review from perspective of removal on surgical unit as well as initiating line/drain/airway entry into the medical record in the operating room. Referrals also made to surgical peer review for documentation concerns and to ed and radiology peer review for the missed retained foreign body.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075709
• MDR Report Key: 7317054
• Date Received: 2018-03-05
• Date of Report: 2018-03-02
• Date of Event: 2018-01-17
• Date Added to Maude: 2018-03-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• 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: 0

Device Details

• Brand Name: SURGICAL DRAIN
• Generic Name: SURGICAL DRAIN
• Product Code: GBP
• Date Received: 2018-03-05
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: UNK

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization	2018-03-05