MAUDE Adverse Event Report: MMJ SA DE CV(USD) MALLINCKRODT; AIRWAY, ESOPHAGEAL (OBTURATOR)

Model Number 5-18437

Device Problem Material Puncture/Hole (1504)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the device's main balloon had pin hole.The customer had no reported patient outcome.

• Brand Name: MALLINCKRODT
• Type of Device: AIRWAY, ESOPHAGEAL (OBTURATOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 15 hampshire street; mansfield, MA 02048 ; 3035306582
• MDR Report Key: 7502814
• MDR Text Key: 107863630
• Report Number: 2936999-2018-00334
• Device Sequence Number: 1
• Product Code: CAO
• UDI-Device Identifier: 10884521105553
• UDI-Public: 10884521105553
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K875226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2022
• Device Model Number: 5-18437
• Device Catalogue Number: 5-18437
• Device Lot Number: 17C0861JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/02/2018
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention