FDA Adverse Event
Other
Summary report: N
LIPPES LOOP DOUBLE S INTRAUTERING DEVICE
MDR report key: 112433
·
Received August 5, 1997
Report
- Report Number
- 2211100-1997-00001
- Event Type
- Other
- Date Received
- August 5, 1997
- Report Date
- March 11, 1997
- Manufacturer
- R.W. JOHNSON PHARM RESEARCH INSTITUTE
- Product Code
- HDT
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
A FEMALE PT REPORTS SHE HAD A LIPPES LOOP DOUBLE S INTRAUTERINE DEVICE INSERTED IN 1992. STATE SHE EXPERIENCED SEVERE PAIN AND BLEEDING FOR THE MONTH THE DEVICE WAS IN PLACE. STATES SHE HAD TO GO TO THE ER BECAUSE SHE "HEMORRHAGED" AND THE DEVICE THEN REMOVED. STATES SHE HAD HEAVY AND IRREGULAR BLEEDING FOR ONE YEAR. PT DID NOT PROVIDE INFO FOR F/U.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIPPES LOOP DOUBLE S INTRAUTERING DEVICE Implant | IUD | HDT | R.W. JOHNSON PHARM RESEARCH INSTITUTE | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |