MAUDE Adverse Event Report: NEW WORLD MEDICAL, INC. AHMED GLAUCOMA VALVE; GLAUCOMA SHUNT

Model Number M4

Device Problem Defective Component (2292)

Patient Problem No Code Available (3191)

Event Date 12/16/2014

Event Type  Injury  

Event Description

Doctor has a pt with an implanted m4 with exposed tube.M4 was not implanted by doctor.

Manufacturer Narrative

Doctor (b)(6) contacted new world medical and indicated a pt with an implanted m4 had an exposed tube.Device was not implanted by dr (b)(6).Dr (b)(6) would like to remove the valve entirely and was concerned about difficulty of m4 removal.Tube exposure is a known complication.Info on how to explant the valve and patching info was provided to dr (b)(6) on (b)(6) 2014.Dr (b)(6) was contacted on (b)(6) 2015 as a follow up to find out if the valve had been actually explanted.He indicated: "the m4 implant had been done about 6 months previously.At revision on (b)(6) 2014, i extracted the tube, closed the sclerostomy, and removed the "slipped" corneal patch, which did not appear to have been sutured in place.".

• Brand Name: AHMED GLAUCOMA VALVE
• Type of Device: GLAUCOMA SHUNT
• Manufacturer (Section D): NEW WORLD MEDICAL, INC.; 10763 edison ct.; rancho cucamonga CA 91730
• Manufacturer (Section G): NEW WORLD MEDICAL, INC.; 10763 edison ct.; rancho cucamonga CA 91730
• Manufacturer Contact: cristina avalos ; 10763 edison ct.; rancho cucamonga, CA 91730 ; 9094664304
• MDR Report Key: 4434206
• MDR Text Key: 18787700
• Report Number: 1000125279-2015-00001
• Device Sequence Number: 1
• Product Code: KYF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060644
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: M4
• Device Catalogue Number: M4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2014
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention