MAUDE Adverse Event Report: GRACE MEDICAL, INC. PEDIATRIC BOBBIN VENT TUBE; TYMPANOSTOMY TUBE

Model Number	500-061
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A complaint regarding this part number and lot number combination was not reported to grace medical, inc.No product was returned to grace medical, inc.For evaluation.There were no products in finished goods inventory with this part number and lot number combination to check.The review of the device history records associated with this device and lot number did not find any nonconformance.Additionally, there have been no complaints for this part number and lot number.Limited information is available at this time.If information is received, a follow-up report will be submitted.
Event or Problem Description
During the review of the maude adverse event database on august 19, 2021, it was discovered that a grace medical, inc.Pediatric bobbin vent tube was referenced in mdr report number 1(b)(4) by a user facility, and received by fda on 7/30/2021.The following event was reported by the user facility as follows: model number: 500-061; (b)(4).Event date: (b)(6) 2021; event type: malfunction.Event description: "the titanium tube placed in the left ear drum for a bilateral myringotomy with tube placement fell forward into the middle ear." the lot number reported is lot number 58580.

• Brand Name: PEDIATRIC BOBBIN VENT TUBE
• Common Device Name: TYMPANOSTOMY TUBE
• Manufacturer (Section D): GRACE MEDICAL, INC.; 8500 wolf lake drive; suite 110; memphis TN 38133 4104
• MDR Report Key: 12463519
• Report Number: 1000022662-2021-00002
• Device Sequence Number: 14744676
• Product Code: ETD
• UDI-Device Identifier: 00844505002547
• UDI-Public: 00844505002547
• Combination Product (Y/N): N
• PMA/510(K) Number: K943325
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/28/2022
• Device Model Number: 500-061
• Device Catalogue Number: 500-061
• Device Lot Number: 58580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2021
• Initial Report FDA Received Date: 09/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention