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

Catalog Number UNK KELLER FUNNEL2

Device Problems Nonstandard Device (1420); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/10/2020

Event Type  malfunction  

Manufacturer Narrative

Further information from the reporter regarding product details has been requested.No additional information is available at this time.The device is not available for return.Reason for reoperation: implant damaged, lubricity.This is a known potential adverse event addressed in the product labeling.

Event Description

Healthcare professional reported "on second side the implant would not go down funnel" and "the funnel split the implant.".

• Brand Name: UNK KELLER FUNNEL2
• 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: michelle burgess ; 12331-a riata trace parkway; building 3; austin, TX 78727 ; 7372473605
• MDR Report Key: 10260712
• MDR Text Key: 198864288
• Report Number: 3011299751-2020-00225
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK KELLER FUNNEL2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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