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

Model Number HA-005

Device Problem Microbial Contamination of Device (2303)

Patient Problem Failure of Implant (1924)

Event Date 07/19/2021

Event Type  malfunction  

Manufacturer Narrative

Lot number 20l15c, expiration date 12/07/2022.Device manufacture date: 12/07/2020.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 requested.No additional information is available at this time.Reason for reoperation: n/a backup device was used for operation.

Event Description

Healthcare professional reported "hair was visible in a new packaged keller funnel." no contact with patient occurred.Surgery was completed with backup device.

Manufacturer Narrative

Additional, changed, and/or corrected data: a2, g1.

Event Description

Healthcare professional reported "hair was visible in a new packaged keller funnel." no contact with patient occurred.Surgery was completed with backup device.

• Brand Name: KELLER FUNNEL2 (5PK)
• Type of Device: 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: 12337920
• MDR Text Key: 267114370
• Report Number: 3011299751-2021-03056
• Device Sequence Number: 1
• Product Code: KDD
• UDI-Device Identifier: 10888628043725
• UDI-Public: 10888628043725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HA-005
• Device Catalogue Number: HA-005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 26 YR