MCM SLEEP DEVICE

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for MCM SLEEP DEVICE manufactured by Unk.

Event Text Entries

[81401139] In (b)(6) hospital, belly pain from a shock treatment. Pt was exposed to red residue that led to irritation of the skin, was given mupirocin ointment that irritated the skin leading to after effects of blistering in skin, burning skin and itching ultimately scarring, pt also had allergic reaction to buspar. My face is a nasty brown color and (b)(6) hospital offer i had a pizza, i felt a shock for 12 hrs. I hit the floor and could not get up. My belly has acid and an h2o sound that i have never had until i ate at (b)(6) hospital and they gave me a shock treatment in my food. And tip top soup and / (b)(6), in this local area i buy things to eat pudding and spices, they do not taste right. Please send me a form so i can send in about my dead mcm device and let the fda know about the sleep device she had at the house. She had to keep replacing it i think the guy next door broke it. He broke in and broke her medical device. And he still brakes in my home putting h2o in my over the counter meds and gets in my food in the fridge, opens the tops and my food in bags, i think he's trying to make me sick so is a girl named (b)(6). And when i was at work at (b)(6), i got sick they had a (b)(6) truck at the work place. I would like to know if it fda approved and my mcm medical device and the shock treatment that was put in my food at (b)(6) hospital. You can get more info about the meds that i have side effects on and the eeoc has faxed paper work from me. Stomatitis cocktail #2 that burns my mouth very bad and clozapine that make me sick to my belly. (b)(6). Ps: he has spy glasses and he's making me sick over and so has co-workers they put hot sauce in my soup when i put it down to take it home to eat. They are hurting my belly.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5071279
MDR Report Key6750786
Date Received2017-07-26
Date of Report2017-07-17
Date of Event2017-04-17
Date Added to Maude2017-07-28
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMCM SLEEP DEVICE
Generic NameSLEEP APPLIANCE WITH PATIENT MONITORING
Product CodePLC
Date Received2017-07-26
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerUNK
Manufacturer AddressUNK UNK


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Deathisabilit 2017-07-26

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.