MAUDE Adverse Event Report: INVAMEX DROP ARM COMMODE 9153630715; ADAPTOR, HYGIENE

Model Number 9669

Device Problem Scratched Material (3020)

Patient Problem Laceration(s) (1946)

Event Type  malfunction  

Event Description

End user reported that when he was getting off of his (b)(4) commode he sustained a hairline papercut on his pelvis/lower spine from a sharp plastic piece on the seat.The wound turned into a stage 4 pressure sore, 3x3 diameter.The nurses had to dress and pack the wound every other day.

• Brand Name: DROP ARM COMMODE 9153630715
• Type of Device: ADAPTOR, HYGIENE
• Manufacturer (Section D): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer (Section G): INVAMEX; parque industrial manimex; reynosa 8878 0; MX 88780
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44036 ; 8003336900
• MDR Report Key: 4507222
• MDR Text Key: 16302820
• Report Number: 9616091-2015-00455
• Device Sequence Number: 1
• Product Code: ILS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 9669
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Weight: 77