MAUDE Adverse Event Report: ALLERGAN (KELLER) KELLER FUNNEL2 (5PK); KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	HA-005
Medical Device Problem Code	Inadequate Lubrication (4057)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Healthcare professional reported "once they dropped the implant into the funnel, the implant would not propel into the pocket".Device was not implanted.
Additional Manufacturer Narrative
Clarification d.4 lot number : 23l15c.A review of the device history record has been initiated.F any new, changed or corrected information is noted, a supplemental medwatch will be submitted.Further information from the reporter regarding event, product, or patient details has been requested.No additional information is available at this time.Reason for reoperation: inadequate lubrication.
Additional Manufacturer Narrative
Additional, changed, and/or corrected data: d1, d3, d4, g1, h4, h6.
Event or Problem Description
Healthcare professional reported "once they dropped the implant into the funnel, the implant would not propel into the pocket".Device was not implanted.

• Brand Name: KELLER FUNNEL2 (5PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 1239 se indian street; suite 112; stuart FL 34997
• Manufacturer (Section G): ALLERGAN (KELLER); 1239 se indian street; suite 112; stuart FL 34997
• Manufacturer Contact: terry ingram ; 1239 se indian street; suite 112; stuart, FL 34997 ; 7722199993
• MDR Report Key: 22436623
• Report Number: 3011299751-2025-00087
• Device Sequence Number: 17301213
• Product Code: KDD
• UDI-Device Identifier: 10888628043725
• UDI-Public: (01)10888628043725(10)23L15C(11)231212(17)251212
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 12/12/2025
• Device Catalogue Number: HA-005
• Device Lot Number: 23L15C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 12/12/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown