D
Patient 1
DURING A HYSTEROSCOPY-DNC, THE PHYSICIAN ATTEMPTED TO REMOVE THE DILATERIA BY PULLING THE STRING. THE DILATERIA BROKE. THE PHYSICIAN REMOVED THE PIECES. THE PATIENT WAS PRESCRIBED ANTIBIOTICS.
MAUDE MDR 997616
- MDR report key
- 997616
- Report number
- 1216677-2008-00004
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-01-29
- Date received
- 2008-02-12
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- THOMAS WILLIAMS
- Address
- 95 CORPORATE DR. TRUMBULL CT 06611 US
- Phone
- 203-203-2036
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MILEX | DILATERIA | COOPERSURGICAL, INC. | HDY | MX210 | 55025 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-02-12 | 0 | 1. R |
Event Narratives#
N
Patient 1
PROPER REMOVAL OF THE DILATERIA IS TO USE GENTLE FORCE USING FORCEPS TO GRASP THE TIP OF THE DILATERIA. THE INSTRUCTIONS FOR USE STATE IN TWO PLACES NOT TO PULL ON THE STRING TO REMOVE - ONCE IN THE WARNINGS SECTION AND AGAIN, IN THE DILATERIA REMOVAL INSTRUCTIONS.