MAUDE Adverse Event Report: MENTOR WORLDWIDE LLC MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER; SIZER, MAMMARY, BREAST IMPLANT VOLUME

Catalog Number	RSZSHPX450S
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the device has not been returned for analysis, no product failure analysis can be conducted.As such, the investigation will be closed.If the complaint device is received in the future, the investigation will be reopened and conducted as appropriate.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6)-year-old female had two 450 cc mentor memorygel xtra resterilizable gel sizers erroneously implanted.The scrub nurse handed the physician brand new sterile re-sterilizable gel sizers during surgery that were mistakenly implanted into the patient.The patient underwent explantation of the sizers.The physician expressed that the difference in superficial packaging and appearance of the sizers and implants were not immediately obvious to her.Pictures of the explanted sizers were received from the customer, and the sizers were marked, "not for implant".This is off label use of the product.No mentor representative was present during the procedure.No patient consequence, with exception to explantation procedure, was reported.See 3006942524-2019-00506 for contralateral prosthesis report.
Additional Manufacturer Narrative
Additional information was received.The event date was and implant dates were updated to (b)(6) 2018.Manufacturer¿s reference number: (b)(4).
Additional Manufacturer Narrative
The investigation of the photograph of the impacted product was completed by the failure analysis lab on 5/20/2019.Device evaluation summary: it was reported that a 37-year-old female had two 450cc mentor memorygel xtra resterilizable gel sizers erroneously implanted.The scrub nurse handed the physician brand new sterile re-sterilizable gel sizers during surgery that were mistakenly implanted into the patient.The patient underwent explantation of the sizers.It was not possible to perform a proper product investigation since the device was not returned.Nonetheless, the customer provided some pictures of the actual device involved in the complaint.Based on the pictures, the device appears intact.The complaint cannot be confirmed.No further investigation can be performed at this time.No corrective actions are required.Manufacturer¿s reference number: (b)(4).

• Brand Name: MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER
• Common Device Name: SIZER, MAMMARY, BREAST IMPLANT VOLUME
• Manufacturer (Section D): MENTOR WORLDWIDE LLC; 33 technology drive; irvine 92618
• MDR Report Key: 8418839
• Report Number: 3006942524-2019-00505
• Device Sequence Number: 13965912
• Product Code: MRD
• UDI-Device Identifier: 00081317026266
• UDI-Public: 00081317026266
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K062421
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/10/2022
• Device Catalogue Number: RSZSHPX450S
• Device Lot Number: 7496495
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/19/2019; 05/20/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 04/15/2019; 05/22/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 37 YR