FDA Adverse Event
Other
Summary report: N
ANGIO-SEAL
MDR report key: 149030
·
Received February 12, 1998
Report
- Report Number
- 3014398-1998-00035
- Event Type
- Other
- Date Received
- February 12, 1998
- Date of Event
- January 5, 1998
- Report Date
- January 6, 1998
- Manufacturer
- QUINTON INSTRUMENT CO.
- Product Code
- MGB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
FOLLOWING A DIAGNOSTIC PROCEDURE, AN ANGIO-SEAL DEVICE WAS PLACED AND HAMOSTATIS WAS SUCCESSFULLY ACHIEVED. UPON DISCHARGE FROM THE HOSP, THE PT EXPERIENCED A "STABBING PAIN" AT THE RIGHT GROIN AND QUARTER SIZE HEMATOMA WAS NOTED AT THE SITE. THE PT WAS KEPT OVERNIGHT FOR OBSERVATION AND GIVEN DARVOCET FOR PAIN. THE SWELLING DID NOT INCREASE AND THE PT WAS DISCHARGED HOME ON 01/06/1998. ON 01/06/1998 THE PT STATED THE HEMATOMA WAS DECREASING AND DESPITE CONTINUED PAIN, HE WAS NOT TAKING ANY PAIN MEDICATION. FOLLOW-UP WITH THE PT ON 01/21/1998 INDICATED THE PT'S SYMPTOMS HAVE RESOLVED AND HE IS WITHOUT SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ANGIO-SEAL Implant | HEMOSTATIC PUNCTURE CLOSURE DEVICE | MGB | QUINTON INSTRUMENT CO. | NA | 801515 OR 801519 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NO INFO | Hospitalization |