MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER RSZSHPX450S manufactured by Mentor Worldwide Llc.
[138758411]
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).
Patient Sequence No: 1, Text Type: N, H10
[138758412]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006942524-2019-00505 |
| MDR Report Key | 8418839 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-02-11 |
| Date of Event | 2018-08-15 |
| Date Mfgr Received | 2019-05-20 |
| Device Manufacturer Date | 2017-08-15 |
| Date Added to Maude | 2019-03-13 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. GABRIEL ALFAGEME |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949789-868 |
| Manufacturer G1 | MENTOR TEXAS |
| Manufacturer Street | 3041 SKYWAY CIRCLE NORTH |
| Manufacturer City | IRVING TX 75038 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75038 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MENTOR MEMORYGEL XTRA RESTERILIZABLE GEL SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2019-03-13 |
| Catalog Number | RSZSHPX450S |
| Lot Number | 7496495 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR WORLDWIDE LLC |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-03-13 |