CHAIT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-05 for CHAIT manufactured by Cook Medical.

Event Text Entries

[104720008] On (b)(6) 2018 surgeon removed the previous chait and replaced it with a new 24 cm chait. After removal a small hole was noted just prior to the turns of the chait. Per surgeon this is the third occurrence of the chait having a tear in the same place requiring replacement.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5076354
• MDR Report Key: 7402262
• Date Received: 2018-04-05
• Date of Report: 2018-04-04
• Date of Event: 2018-03-20
• Date Added to Maude: 2018-04-06
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: CHAIT
• Generic Name: CECOSTOMY BUTTON/TUBE
• Product Code: GCE
• Date Received: 2018-04-05
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COOK MEDICAL
• Manufacturer Address: BLOOMINGTON IN 47402 US 47402

Device Sequence Number: 2

• Brand Name: CHAIT
• Generic Name: CECOSTOMY BUTTON/TUBE
• Product Code: GCE
• Date Received: 2018-04-05
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: COOK MEDICAL
• Manufacturer Address: BLOOMINGTON IN 47402 US 47402

Device Sequence Number: 3

• Brand Name: CHAIT
• Generic Name: CECOSTOMY BUTTON/TUBE
• Product Code: GCE
• Date Received: 2018-04-05
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: COOK MEDICAL
• Manufacturer Address: BLOOMINGTON IN 47402 US 47402

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2018-04-05