MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES ZIPPIE 2; MANUAL WHEELCHAIR

Model Number EIZ2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Laceration(s) (1946)

Event Date 11/08/2018

Event Type  Injury  

Manufacturer Narrative

The injury was not to the user of the chair, nor was it due to a malfunction or defect.The chair's caster fork contributed to the injury that required stitches when the mother attempted to break her daughter's (end user's) fall when her daughter was standing next to her chair and therefore accidentally stumbling with her daughter.There has not been any previous incident(s) of this type involving a wheelchair caster fork and there was no allegation of malfunction or defect made against the subject wheelchair.Sunrise medical considers this an isolated incident, however, will be monitored for trends.No further action will be taken by sunrise medical at this time.

Event Description

The father of the end user reported on (b)(6) 2018 that his wife, (b)(6), required stitches on her foot when she got cut on his daughter's zippie 2 wheelchair's caster fork.Per the husband, saturday morning at breakfast, his daughter was standing next to her zippie 2 when she stumbled.When his wife attempted to break the daughter's fall, (b)(6) foot went under the chair.Her foot was severely cut by the pointed end of the front wheel's caster fork.(b)(6) did require immediate medical attention and stitching on her foot.

• Brand Name: ZIPPIE 2
• Type of Device: MANUAL WHEELCHAIR
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 parque industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, CA 93727 ; 5592942840
• MDR Report Key: 8144581
• MDR Text Key: 129745748
• Report Number: 9616084-2018-00012
• Device Sequence Number: 1
• Product Code: IOR
• Combination Product (y/n): N
• PMA/PMN Number: K973673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: EIZ2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention