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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONVAQUIP INDUSTRIES, INC. CONVAQUIP 930XL BARIATRIC WHEELCHAIR

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CONVAQUIP INDUSTRIES, INC. CONVAQUIP 930XL BARIATRIC WHEELCHAIR Back to Search Results
Model Number 930XL
Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Patient Problems Laceration(s) (1946); Injury (2348); Suture Abrasion (2497)
Event Date 04/23/2015
Event Type  Injury  
Event Description
Per facility report- patient sat down in bariatric wheelchair.Instead of placing hand on arm of wheelchair, hand was placed under the seat of the wheelchair.When the patient sat down, she pinched her middle finger between the seat and the bar of the wheelchair causing her finger to be injured.Nail of finger was black with blood oozing from it and laceration was noted.Physician checked patient.Nail was removed and sutures x 2 were placed.Patient was also seen by hand specialist and had an x-ray done.
 
Manufacturer Narrative
Improper use of device contributed to injury.Owner's manual provides clear opening and closing chair instructions.
 
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Brand Name
CONVAQUIP 930XL BARIATRIC WHEELCHAIR
Type of Device
BARIATRIC WHEELCHAIR
Manufacturer (Section D)
CONVAQUIP INDUSTRIES, INC.
abilene TX
Manufacturer Contact
500 county rd 239
abilene, TX 79601
3256774177
MDR Report Key4808821
MDR Text Key5922020
Report Number1629847-2015-00001
Device Sequence Number1
Product Code INM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/29/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number930XL
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/20/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
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