MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-04-13 for MENTOR manufactured by Mentor Texas L.p..
[105394184]
Patient Sequence No: 1, Text Type: N, H10
[105394185]
Breast sizers leave residue following reprocessing on at least three occasions. This resulted in unusable product and potential delays in patient care as new sizers are located. It is unclear what effect the residue would have if used on a patient if caught. Reprocessing was observed by manufacturer and found to meet recommended standards per ifu. Manufacturer response for resterilizable gel breast implant sizer, (brand not provided) (per site reporter). The manufacturer has visited our facility to observe the reprocessing process. We have been told reprocessing is being done correctly and there is no explanation for the residue. We are currently awaiting guidance from the manufacturer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7428562 |
| MDR Report Key | 7428562 |
| Date Received | 2018-04-13 |
| Date of Report | 2018-03-23 |
| Date of Event | 2018-03-01 |
| Report Date | 2018-03-23 |
| Date Reported to FDA | 2018-03-23 |
| Date Reported to Mfgr | 2018-03-23 |
| Date Added to Maude | 2018-04-13 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MENTOR |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-04-13 |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR TEXAS L.P. |
| Manufacturer Address | 555 AIRLINE DRIVE COPPELL TX 75019 US 75019 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-04-13 |