MAUDE Adverse Event Report: SUNRISE MEDICAL PRIVADA MISIONES JAY; JAY CUSHION

Model Number M2446N

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pressure Sores (2326)

Event Date 05/11/2020

Event Type  Injury  

Manufacturer Narrative

The jay cushion involved in this adverse event did not malfunction nor is it defective.The dealer stated that "the area of the transition of the well was too aggressive for the client." client is 5'4" (b)(6) pounds, client was seen by the doctor on or about (b)(6) 2020, is receiving general wound care each week, will have weekly follow ups for the next 4 weeks.Based on the information provided by the dealer, it is our reasonable conclusion that the dealer provided the end user a cushion that was not suitable for their needs.The end user has now been provided a jay union cushion by the dealer which is more suitable for their needs.

Event Description

Client has received pressure sores from the m2446n j2dc cushion.Client has cuts to the inner thighs that have opened and bled.Sunrise was made aware of this incident on (b)(6)2020.

• Brand Name: JAY
• Type of Device: JAY CUSHION
• Manufacturer (Section D): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 privada industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer (Section G): SUNRISE MEDICAL PRIVADA MISIONES; no. 110 privada industrial; misiones de las californias; tijuana, baja california 22425 ; MX 22425
• Manufacturer Contact: gustavo zambrano ; 2842 business park ave.; fresno, ca ; 2942840
• MDR Report Key: 10248553
• MDR Text Key: 198081135
• Report Number: 9616084-2020-00003
• Device Sequence Number: 1
• Product Code: IMP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• 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: 06/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: M2446N
• Device Catalogue Number: M2446N
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/14/2020
• 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): Other
• Patient Weight: 46