MAUDE Adverse Event Report: UNKNOWN STAPLE, IMPLANTABLE

Device Problem Defective Component (2292)

Patient Problems Pain (1994); Septic Shock (2068); Tissue Damage (2104)

Event Date 06/10/2019

Event Type  Injury  

Event Description

Original colon surgery on (b)(6) 2019.On (b)(6) 2019 my husband suffered sever pain and had to be readmitted to the hospital.After 2 days of testing, emergency surgery was performed late night on (b)(6) 2019.The surgeon told me a staple had failed and my husband may not make it through the night because he was now septic.He did survive, was in intensive/progressive care of 15 days and is now in a rehabilitation hospital.He now had a colostomy bag and a large open wound on his stomach that measures 5 inches long 3 inches wide and about 2.5 inches deep.I was told his recovery could take months.Not only was he affected physically but also mentally.He can still think for himself but his thinking process can sometimes be very slow.This info needs to be provided by doctor (b)(6).

• Brand Name: STAPLE, IMPLANTABLE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 8764211
• MDR Text Key: 150521866
• Report Number: MW5087898
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Disability
• Patient Age: 78 YR
• Patient Weight: 91