TISSUEGLU

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-16 for TISSUEGLU manufactured by Cohera.

Event Text Entries

[100560390] I had a tummy tuck on (b)(6) 2016 and cohera tissue glue was used. It never dissolved in my body and had to have surgery (b)(6) 2017. From (b)(6) 2017 i was going to doctor office every other day to have fluid drained until last surgery fluid level kept going up. Mid (b)(6) 2017 i had a drainage tube and had to keep a (b)(6) pad over it to catch fluid. It had to be changed 3x a day. From first surgery to last doctor had to place approx 5 different tubes due to different circumstances. Last surgery doctor had to open me completely back up and scrape material out. I still have some samples in my freezer. Can you tell me if anyone else has had similar experience with this product? I called the company numerous times to no avail - no one would call me back. Until early morning on way to last surgery twas a bit late by that time. I need to speak with someone for months leading up to this point. Would appreciate any info you could pass on to me. Thank you. (b)(6).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5075328
• MDR Report Key: 7281914
• Date Received: 2018-02-16
• Date of Report: 2018-02-15
• Date of Event: 2016-08-29
• Date Added to Maude: 2018-02-20
• 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: TISSUEGLU
• Generic Name: SURGICAL ADHESIVE FOR INTERNAL USE
• Product Code: PJK
• Date Received: 2018-02-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COHERA

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-02-16