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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: device was not implanted.
Event or Problem Description
Healthcare professional reported "the implant would not propel into the pocket".A backup keller funnel was used to complete surgery.

• 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 CA
• Manufacturer Contact: terry ingram ; 2525 dupont drive; irvine, CA 78759 ; 8479366324
• MDR Report Key: 22416761
• Report Number: 3011299751-2025-00086
• Device Sequence Number: 15198325
• Product Code: KDD
• UDI-Device Identifier: 10888628043725
• UDI-Public: (01)10888628043725
• 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
• Report Date (Section B): 07/07/2025

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 Catalogue Number: HA-005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/07/2025
• 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