MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MEXICO DURAPLUG; EXTENDED WEAR PUNCTUM PLUG

Model Number 0078

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

Patient Problems Discharge (2225); No Code Available (3191)

Event Date 01/15/2020

Event Type  Injury  

Manufacturer Narrative

No samples were returned for review/testing.No retains are available for review.A review of the device history and sterilization records confirmed the material meets all current specification.No quality issues were noted throughout the incoming inspection, manufacturing, in-process or final inspection process.No other complaints were received for this finished good lot.Without receiving details regarding the pre-operative preparation of the device(s), procedure performed, patient's past and current allergy history, results of culture and/or sensitivities tests or reactions to suture material, post-operative events that may have resulted in an infection or discomfort(rubbing the eye, unsanitary conditions, not following post-operative care) or the surgeon's technique, a definitive root cause cannot be confirmed at this time.Patients prone to eye infections or have a case of severely dry eyes may not respond well to plug placement.The most common side effects include scratchy irritation near the insertion site/punctum, inflammation, allergic reaction, watery eyes or the plug sticking out or become extracted either due to the body rejecting the plug entirely or possibly due to the insertion of an incorrect size device.

Event Description

The doctor placed dura plugs in the ducts of the patient as an alternative treatment for dry eye after trying eye drops and placement of short term collagen plugs.There was problem reported at first, but then her eyes were constantly tearing and there was also a thick white discharge (this discharge was not confirmed by her doctors as she wiped it away) reported by the patient.The patient could not provide an approximate date as to when this issue started.She disclosed that she saw three (3) doctors about the issue.On (b)(6) 2020, the doctor removed the left eye plug but was unable to see or retrieve the plug from the right eye canaliculus canal.On (b)(6) 2020, her left eye was no longer tearing, but right eye was still tearing.She was instructed to have allergy testing performed.No additional details received to date.

• Brand Name: DURAPLUG
• Type of Device: EXTENDED WEAR PUNCTUM PLUG
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION MEXICO; corredor tijuana rosarito 2000; #24702 b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 9695289
• MDR Text Key: 192405341
• Report Number: 3010692967-2020-00009
• Device Sequence Number: 1
• Product Code: LZU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/01/2005,02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 0078
• Device Catalogue Number: 0078
• Device Lot Number: AADN965
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Event Location: Home
• Date Report to Manufacturer: 01/21/2020
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR