MAUDE Adverse Event Report: COVIDIEN LINER STAPLE ; STAPLE, IMPLANTABLE

Lot Number 3400

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

Patient Problems Wound Dehiscence (1154); Abscess (1690); Unspecified Infection (1930); Pain (1994)

Event Date 10/18/2019

Event Type  Injury  

Event Description

Pt was admitted for surgery (b)(6) 2019 with dx rectal ca.He was readmitted (b)(6) 2019 due to rectal pain.Op findings from (b)(6) 2019 include "rectal examination revealed findings consistent with an anastomotic dehiscence, with contaminant within the presacral space, presacral pelvic abscess" which qualifies this case as a surgical site infection (organ/space of the gi tract).Fda safety report id#s (b)(4).

• Brand Name: LINER STAPLE
• Type of Device: STAPLE, IMPLANTABLE
• Manufacturer (Section D): COVIDIEN
• MDR Report Key: 9865162
• MDR Text Key: 184665003
• Report Number: MW5093869
• Device Sequence Number: 4
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/18/2020
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: 3400
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 101