MAUDE Adverse Event Report: SEKISUI DIAGNOSTICS OSOM ULTRA STREP A TEST 50T

Catalog Number 149

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

Patient Problems Distress (2329); Device Embedded In Tissue or Plaque (3165)

Event Date 09/20/2019

Event Type  malfunction  

Manufacturer Narrative

This report involves specifically the puritan swabs, which are puritan branded and manufactured and packaged as a part of the sekisui diagnostics osom ultra strep a test kits.

Event Description

Customer sent a letter to sekisui stating that during the routine swabbing of a (b)(6) year old child, the child bit down on the swab and a 6 cm piece became lodged in the child's throat.Before the physician could remove the swab, the child swallowed the swab.The parents were required to sift through the child's feces for a few days until the swab bit was located.The child did pass the swab and the parents were able to find it.

• Brand Name: OSOM ULTRA STREP A TEST 50T
• Type of Device: STREP A
• Manufacturer (Section D): SEKISUI DIAGNOSTICS; 6659 top gun st; san diego CA 92121
• Manufacturer (Section G): SEKISUI DIAGNOSTICS; 6659 top gun st; san diego CA 92121
• Manufacturer Contact: dave simard ; 1 wall st; burlington, MA 01803
• MDR Report Key: 9313517
• MDR Text Key: 204720725
• Report Number: 1000520007-2019-00001
• Device Sequence Number: 1
• Product Code: GTZ
• UDI-Device Identifier: 00742860001413
• UDI-Public: 00742860001413
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K961423
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 149
• Device Lot Number: 191265
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 MO