D-STAT INJECTABLE *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-02-22 for D-STAT INJECTABLE * manufactured by *.

Event Text Entries

[598882] I am diagnosed with lymphoma after abdominal mass was found on physical exam and ct scan. In 2007, i underwent abdominal lymph node needle biopsy with 19 gauge needle by a radiologist. After procedure was done, oozing of blood was noted from needle through which biopsy was taken. The radiologist, instead of observing and waiting for bleeding to stop on its own, he injected d-stat, a liquid bovine thrombin. Minutes later, i developed severe abdominal pain and suffered a bowel infection. Two days later, 6 feet of small bowel were removed. I was in hospital 9 days. Pathology showed normal bowel that was gangrenous. I believe i had received intra-arterial injection.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

Report Number	MW1042600
MDR Report Key	839065
Date Received	2007-02-22
Date of Report	2007-02-09
Date of Event	2005-02-15
Date Added to Maude	2007-04-20
Event Key	0
Report Source Code	Voluntary report
Manufacturer Link	N
Number of Patients in Event	0
Adverse Event Flag	3
Product Problem Flag	3
Reprocessed and Reused Flag	3
Reporter Occupation	PATIENT
Health Professional	3
Initial Report to FDA	3
Report to FDA	3
Event Location	3
Single Use	0
Previous Use Code	0
Event Type	3
Type of Report	3

Device Details

Brand Name	D-STAT INJECTABLE
Generic Name	*
Product Code	MHW
Date Received	2007-02-22
Model Number	*
Catalog Number	*
Lot Number	*
ID Number	*
Device Availability	*
Device Age	*
Implant Flag	N
Date Removed	*
Device Sequence No	1
Device Event Key	826369
Manufacturer	*
Manufacturer Address	* * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit	2007-02-22