N
Patient 1
DEVICE WAS USED AFTER ITS LABELED EXPIRATION DATE. BROKEN PIECE WAS REMOVED WITHOUT COMPLICATIONS.
MAUDE MDR 3136322
- MDR report key
- 3136322
- Report number
- 3003994796-2013-00002
- Event key
- 0
- Event type
- 3
- Date of event
- 2013-04-09
- Date received
- 2013-05-06
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Address
- KARLOVARSKA TRIDA 20 KAMENNE ZEHROVICE 273 0 EZ
- Phone
- 317-317-3170
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | DILAPAN-S | DILAPAN-S | MEDICEM TECHNOLOGY | LOB | 4X55 | DS030407455 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-05-06 | 0 | 1. R |
Event Narratives#
D
Patient 1
DILAPAN-S WERE USED AFTER EXPIRATION (MAY 2010). DURING EXTRACTION ONE OF THEM BROKE LEAVING A PIECE IN UTERUS. BROKEN PIECE WAS REMOVED SUBSEQUENTLY.