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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMIGO MOBILITY INTERNATIONAL AMIGO, MODEL SMART SHOPPER 420000 (ARMLESS); HANDICAP SHOPPING CART/VEHICLE, MOTORIZED 3-WHEELED

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AMIGO MOBILITY INTERNATIONAL AMIGO, MODEL SMART SHOPPER 420000 (ARMLESS); HANDICAP SHOPPING CART/VEHICLE, MOTORIZED 3-WHEELED Back to Search Results
Model Number SMART SHOPPER
Device Problems Unintended Collision (1429); Use of Device Problem (1670)
Patient Problems Bruise/Contusion (1754); Crushing Injury (1797); Pain (1994); Swelling (2091)
Event Date 12/20/2016
Event Type  No Answer Provided  
Event Description
I am writing to you with a serious safety concern, following an incident that occurred at the (b)(6) commissary at 3:00 p.M., (b)(6) 2016.I was completing my shopping at the egg section, which has a refrigerated case with metal shelving and glass doors which open like a refrigerator door with a handle.I opened the egg compartment door, which opened left to right, grasping the door's edge with the fingers of my right hand, below the door's handle.As i reached down to get a carton of eggs, i heard voices shouting "stop".I stood up then felt an object ramming my backside and thighs, pushing me into the shelving from the waist down while my back was hyper extended as i tried to not fall; at the same time the four fingers of my right hand were jammed under the handle of the glass door, and my fingers and upper arm were hyper extended backward, all in an unnatural position.The pain in my fingers, wrist, arm, thighs, legs and back and backside was excruciating and i shouted constantly as i was pushed further into the compartment, wedging me into the shelving area.I could not move, as the pressure continued and all the areas impacted became more and more painful.I heard frantic shouting "mother, stop" i think but i was rather in shock.Finally, the pain stopped and someone told me a cart (which was a motorized shopping cart) had run into me.I reached for my own shopping cart and felt dazed and weak.A man asked if i needed help.I replied i needed a moment.I wasn't sure of my physical state and whether i had cuts or fractures.This man told me i should go to the mgr's office to write a report and sit down.He walked with me as i held on to the shopping cart and slowly made my way.He told me his name, that his mother-in-law was driving the cart, that as she headed towards me in the (motorized) cart his wife told her mother to stop, but that he expected his mother may have panicked and accelerated, going forward, instead of stopping, ran into me, and continued accelerating.At the mgr's office, a customer service staff member kindly opened the office door, got me a chair, and called for the manager.She was polite and asked if i needed medical assistance (not her exact words).I declined, as although i was in pain, and had tenderness in my hand, wrist, fingers, lower back, and knee joints.I was not bleeding and saw no evidence of fracture (i am a retired nurse).The mgr then said she needed to make a report.She asked me and the witness a series of questions regarding what had happened, and requested our contact info.The witness left, and i asked for the manager's contact info.Another apparent gentleman came to the office and asked what had happened.The manager told him, "she (meaning me) was pushed "a little" (direct quote) into a glass door." i was alarmed that her statement did not accurately reflect what had happened and i subsequently saw no copy of her report.As an aside, i am a retired rn with a ph.D.In public policy.I have taught and practiced professional nursing since 1969, and held positions in education, policy research, and advocacy.The last position i held was senior investigator, (b)(6).I am familiar with administrative law, accountability, and the need for accurate info to be made available to senior administrators to improve services.At home, my husband checked me and found a welt and two small bruises in affected areas.I took something for pain and am observing myself for further injury.I am especially concerned about my right arm, hand and fingers because, due to breast cancer, i have no lymph nodes in my right arm, and any injury can cause complications to my current lymphedema.I went to the (b)(6)medical center ((b)(6)) and was seen in the emergency room as my pain had increased significantly.In addition to my emergency room visit, i have had two f/u visits to (b)(6) primary care clinic for continued pain at the site of my injuries sustained at the (b)(6) commissary.I was prescribed medication to ameliorate my pain and also was referred to physical therapy by my doctor.I followed through with my first physical therapy appointment, which helped relieve some muscle pain.Unfortunately, prior to my next scheduled appointments, my husband (b)(6), a thirty-year navy veteran, became severely ill, was seen in the emergency room and was hospitalized in the intensive care unit and the medical unit at (b)(6) for 6 days, during which i gladly spent countless hours with him.He was discharged to home requiring personal and nursing care, which i have provided to the best of my abilities.He is still requiring care and f/u, as am i.I am concerned about the safety of other shoppers who are in the same facility as those operating mechanical shopping carts.Other shoppers, including wounded warriors or others with impaired mobility, parents and children who shop at the (b)(6) commissary, as well as employees and vendors, might be injured by a mechanical shopping cart that has no mechanism to automatically stop before it collides with anyone or anything.Further, i believe no motorized shopping cart should travel faster than any customer who is walking.(b)(6).
 
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Brand Name
AMIGO, MODEL SMART SHOPPER 420000 (ARMLESS)
Type of Device
HANDICAP SHOPPING CART/VEHICLE, MOTORIZED 3-WHEELED
Manufacturer (Section D)
AMIGO MOBILITY INTERNATIONAL
6693 dixie highway
bridgeport MI 48722
MDR Report Key6692622
MDR Text Key80024532
Report NumberMW5070824
Device Sequence Number1
Product Code INI
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2017
Device Operator No Information
Device Model NumberSMART SHOPPER
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age69 YR
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