MAUDE Adverse Event Report: DENTSPLY PROFESSIONAL SPOROX II STERILIZING AND DISINFECTING SOLUTION 1GAL. (3.8L); STERILANT, MEDICAL DEVICES

Catalog Number 0075156FG

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Burning Sensation (2146); Reaction (2414)

Event Date 07/17/2017

Event Type  malfunction  

Manufacturer Narrative

This event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.

Event Description

During a dental procedure, a patient had contact with a lip retractor that had been previously cleaned with sporox ii sterilization and disinfectant solution.The patient felt a burning sensation first in her hand and it turned white, then after ten minutes she felt a burning sensation that went from her esophagus to her stomach.An hour later she was taken to the er.The reaction was immediate after contact with lip retractor.She had no previous symptoms before the contact.The event outcome is unknown as of this mdr evaluation.

Manufacturer Narrative

The device was evaluated and found to be within specification.A dhr review was conducted with no discrepancies noted.

• Brand Name: SPOROX II STERILIZING AND DISINFECTING SOLUTION 1GAL. (3.8L)
• Type of Device: STERILANT, MEDICAL DEVICES
• Manufacturer (Section D): DENTSPLY PROFESSIONAL; 1301 smile way; york PA 17404
• Manufacturer (Section G): DENTSPLY CAULK; 38 w. clark ave.; milford DE 19963
• Manufacturer Contact: helen lewis ; 221 w. philadelphia st.; suite 60w; york, PA 17401 ; 7178494229
• MDR Report Key: 6797392
• MDR Text Key: 82788865
• Report Number: 2424472-2017-00097
• Device Sequence Number: 1
• Product Code: MED
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K990703
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Dentist
• Type of Report: Initial,Followup
• Report Date: 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Catalogue Number: 0075156FG
• Device Lot Number: 170314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 31 YR
• Patient Weight: 45