HYDROGEL INJECTION

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-10-26 for HYDROGEL INJECTION manufactured by .

Event Text Entries

[3105121] Healthy young (b)(6) had self-pay injection of hydrogel into buttock area for cosmetic reasons. First injection was done 1 year ago with smaller dose and no adverse reaction. Second injection was done with no immediate adverse reaction. Five days later developed sig dyspnea and blood streaked sputum. No fever, purulent drainage. Was seen at (b)(6). Wbc was elevated at 14. 7 with 81% pmns. Cxr showed patchy infiltrate and ct chest with diffuse b peripheral ground glass opacities. She was treated for atypical pneumonia with doxycycline and keflex. She was seen in my office the next day without significant improvement. At that time pulse ox 93% on ra and drops to at lower than 86% with slow walking around the hall way. She was given avelox and prednisone 20mg and improved by 2 days with significant clinical improvement. Pulse ox at rest 96% and dropping to 93% with walking. Dates of use: (b)(6) 2012.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5028259
• MDR Report Key: 2887451
• Date Received: 2012-10-26
• Date of Report: 2012-10-26
• Date of Event: 1980-10-23
• Date Added to Maude: 2012-12-28
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Generic Name: HYDROGEL INJECTION
• Product Code: NKN
• Date Received: 2012-10-26
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2012-10-26