MAUDE Adverse Event Report: ALLERGAN (KELLER) KELLER FUNNEL2 (1PK); KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number	HA-001
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
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: "implant ruptured inside the keller funnel before implantation".
Event or Problem Description
Healthcare professional reported "implant ruptured inside the keller funnel before implantation.¿ affected side is unknown.Surgery was completed with backup implant and keller funnel.

• Brand Name: KELLER FUNNEL2 (1PK)
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): ALLERGAN (KELLER); 1239 se indian st; ste 112; stuart FL 34997
• Manufacturer (Section G): ALLERGAN (KELLER); 1239 se indian st; ste 112; stuart FL 34997
• Manufacturer Contact: terry ingram ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 8479366324
• MDR Report Key: 17880169
• Report Number: 3011299751-2023-00145
• Device Sequence Number: 15317659
• Product Code: KDD
• UDI-Device Identifier: 10888628043732
• UDI-Public: 10888628043732
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/05/2023

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-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 73 KG