MAUDE Adverse Event Report: ALLERGAN (KELLER) MOTIVAIMAGINE INSERTION SLEEVE; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number EL-001

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

Healthcare professional reported "the doctor has detached the letters of the insertion sleeve, and it has caused contamination of the field and the implant." device was hydrated using betadine.The device was in contact with the patient's skin."the surgery was completed by washing the inside of the breast pocket profusely to remove the remaining blue lettering and continued as a normal augmentation without using the sleeve.".

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: there was no reoperation as surgery was completed with a backup breast implant.

Event Description

Healthcare professional reported "the doctor has detached the letters of the insertion sleeve, and it has caused contamination of the field and the implant." device was hydrated using betadine.The device was in contact with the patient's skin."the surgery was completed by washing the inside of the breast pocket profusely to remove the remaining blue lettering and continued as a normal augmentation without using the sleeve.".

Manufacturer Narrative

Additional, changed, and/or corrected data: d1, d4.

Event Description

Healthcare professional reported "the doctor has detached the letters of the insertion sleeve, and it has caused contamination of the field and the implant." device was hydrated using betadine.The device was in contact with the patient's skin."the surgery was completed by washing the inside of the breast pocket profusely to remove the remaining blue lettering and continued as a normal augmentation without using the sleeve.".

Manufacturer Narrative

Additional, changed, and/or corrected data: h6.

• Brand Name: MOTIVAIMAGINE INSERTION SLEEVE
• 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: 16322265
• MDR Text Key: 309028838
• Report Number: 3011299751-2023-00018
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: 510(K)EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EL-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• 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): Required Intervention