CATHETER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-24 for CATHETER manufactured by .

Event Text Entries

[41472172] Patient with latex allergy documented as anaphylaxis (some disagreement from family over this, stated it was rash). Patient had a latex containing foley catheter put in. About 6 hours later, while ceftazidime was being administered, patient appeared uncomfortable, with erythema of his skin involving his trunk, back, buttocks, and arms with developing wheals. He also had noticeably more periorbital edema than on original exam, and was complaining of feeling short of breath, despite bipap, hr to 150s. Given concern for anaphylaxis, he was given solumedrol 125mg x 1, pepcid 20mg iv x 1, epi 0. 3mg im x 1, and duoneb/racemic epi. He became hypotensive to sbp 80s and tachypneic, so anesthesia was called to stabilize his airway. Ceftazidime was discontinued. Patient improved within 24 hours. Symptoms: anaphylaxis, angioedema, skin rash, tachypnea, rash. Tachycardia suspect drug #2 dosing: indwelling catheter. Dose or amount: 2gm. Frequency: bid. Route: iv. Event abated after use stopped or dose reduced: yes. Diagnosis for use: sepsis, urinary retention.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5061296
• MDR Report Key: 5532282
• Date Received: 2016-03-24
• Date of Report: 2015-07-04
• Date of Event: 2015-06-29
• Date Added to Maude: 2016-03-29
• 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: PHARMACIST
• 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: CATHETER
• Generic Name: CATHETER
• Product Code: NWR
• Date Received: 2016-03-24
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Life Threatening	2016-03-24