MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-14 for MENTOR RESTERILIZABLE GEL BREAST IMPLANT SIZER 300CC RSZ-3001S manufactured by Mentor Corporation.
[59765442]
Patient Sequence No: 1, Text Type: N, H10
[59765443]
Breast implant sizer dispensed to sterile field. During placement of the sizer into the left breast,the sizer ruptured. Ruptured sizer was removed from the field. A second sizer was dispensed to the sterile field. During placement of the second sizer into the right breast, the sizer ruptured. The ruptured sizer was removed from the field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6099270 |
| MDR Report Key | 6099270 |
| Date Received | 2016-11-14 |
| Date of Report | 2016-09-19 |
| Date of Event | 2016-08-31 |
| Report Date | 2016-09-19 |
| Date Reported to FDA | 2016-09-19 |
| Date Reported to Mfgr | 2016-09-19 |
| Date Added to Maude | 2016-11-14 |
| 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 RESTERILIZABLE GEL BREAST IMPLANT SIZER |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2016-11-14 |
| Model Number | 300CC |
| Catalog Number | RSZ-3001S |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR CORPORATION |
| Manufacturer Address | 3041 SKYWAY CIRCLE NORTH IRVING TX 75038 US 75038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-11-14 |