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	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record has been initiated.If 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/will be requested.No additional information is available at this time.Reason for reoperation: n/a (less lubrication in the keller funnel, a different keller funnel had to be used).
Event or Problem Description
Healthcare professional reported "less lubricant in the funnels or sometimes barely any lubricant.Office has stated " we've noticed lately that there seems to be less lubricant in the funnels, which makes the insertion more difficult, especially if we use sizers after the dentures, sometimes there is almost no lubricant at all, and very difficult to get the dentures in".Later healthcare professional reported "lubricating coating no longer slipped after the first use (needed to use it for a few sizers insert the final implants, had to open new ones during the procedure)".Provider further confirmed this complaint relates to breast implants not "dentures".Patient contact was made.Side is unknown.Device was discarded.

• Brand Name: KELLER FUNNEL2 (5PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 2525 dupont drive; irvine CA 92612
• Manufacturer (Section G): ALLERGAN (KELLER); 2525 dupont drive; irvine 92612
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 92612 ; 8479366324
• MDR Report Key: 24491457
• Report Number: 3011299751-2026-00028
• Device Sequence Number: 5104730
• Product Code: KDD
• UDI-Device Identifier: 10888628043725
• UDI-Public: (01)10888628043725(10)23E20C(11)230515(17)250515
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: 510(K)EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 05/15/2025
• Device Catalogue Number: HA-005
• Device Lot Number: 23E20C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 03/02/2026
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: Female