INTERGEL *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-08-22 for INTERGEL * manufactured by *.

Event Text Entries

[16786031] 2002 pt had surgery to remove mass likely connected to ovary. Intergel was used to prevent further adhesions during the surgery. Pt had only just recovered from this major surgery when pt had to have repeat surgery in 2002. Remaining ovary, which had been treated with intergel, needed to be removed along with encrusted mass. The "wonderdrug" intergel at that time seemed the logical culprit. Have had unexplained pain in back and abdomen since surgery. Their dr finally contacted pt a week ago to let pt know about the recall of intergel and explained he had not only put intergel on ovary in 2002 surgery but on uterus which pt still retains. The second surgery also left pt with no ovaries and considerable distress as they have to take hormone replacement therapy now and it has been months trying to find a combinatin of drugs they can tolerate. Pt also has no children and was -even at this late age- hoping to have them.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1029571
• MDR Report Key: 487687
• Date Received: 2003-08-22
• Date of Report: 2003-08-22
• Date of Event: 2002-06-26
• Date Added to Maude: 2003-10-09
• 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: 0
• Reporter Occupation: PATIENT
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INTERGEL
• Generic Name: *
• Product Code: MLQ
• Date Received: 2003-08-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 476551
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Other	2003-08-22