MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for INSPIRA MSZ-X445 manufactured by Allergan.
[107777674]
Patient Sequence No: 1, Text Type: N, H10
[107777675]
The doctor was performing a bilateral implant exchange and asked for a 470cc sizer ((b)(4)). Sizer was used on pt, and surgeon noticed it had a hole in top of sizer. Leaking area on sizer did not touch pt's tissue. The sizer was removed from field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7498563 |
| MDR Report Key | 7498563 |
| Date Received | 2018-05-09 |
| Date of Report | 2018-04-24 |
| Date of Event | 2018-04-17 |
| Report Date | 2018-04-24 |
| Date Reported to FDA | 2018-04-24 |
| Date Reported to Mfgr | 2018-04-24 |
| Date Added to Maude | 2018-05-09 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INSPIRA |
| Generic Name | SIZER, MAMMARY, BREAST IMPLANT VOLUME |
| Product Code | MRD |
| Date Received | 2018-05-09 |
| Model Number | MSZ-X445 |
| Catalog Number | MSZ-X445 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ALLERGAN |
| Manufacturer Address | 301 W HOWARD LANE SUITE 100 AUSTIN TX 78753 US 78753 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-09 |