FDA Adverse Event
Other
Summary report: N
DILAPAN-S
MDR report key: 3142456
·
Received April 23, 2013
Report
- Report Number
- 3003994796-2013-00001
- Event Type
- Other
- Date Received
- April 23, 2013
- Date of Event
- February 8, 2013
- Report Date
- April 15, 2013
- Manufacturer
- MEDICEM TECHNOLOGY S.R.C.
- Product Code
- LOB
- PMA / PMN Number
- P840045
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
COMPLAINT FORWARDED DISTRIBUTOR IN (B)(4) TO MANUFACTURER. EVENT OCCURRED IN (B)(6).
Description of Event or Problem · 1
DILAPAN-S BROKE DURING EXTRACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 175755 | DILAPAN-S | DILAPAN-S HYGROSCOPIC CERVICAL DILATOR | LOB | MEDICEM TECHNOLOGY S.R.C. | 4X65MM | DS270312465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | Required Intervention |