MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for EXP BRST TISS 650CC SIL 350-9215 manufactured by Mentor Worldwide Llc.
[184840059]
Approx three weeks after procedure, pt began to experience increase in drainage from surgical site and a deflation of the expander. The expander was removed and replaced in the operating room and was found to be ruptured. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093880 |
| MDR Report Key | 9865319 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-19 |
| Date of Event | 2020-01-16 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| 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 | EXP BRST TISS 650CC SIL |
| Generic Name | EXPANDER, SKIN, INFLATABLE |
| Product Code | LCJ |
| Date Received | 2020-03-20 |
| Catalog Number | 350-9215 |
| Lot Number | 9368829 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MENTOR WORLDWIDE LLC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-20 |