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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE RECONSTRUCTIVE HENIA MESH MESH, SURGICAL

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LIFECELL CORPORATION STRATTICE RECONSTRUCTIVE HENIA MESH MESH, SURGICAL Back to Search Results
Model Number 1620002P
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Fatigue (1849); Pain (1994); Seroma (2069)
Event Date 03/08/2022
Event Type  Injury  
Event Description
Hernia repair. My implant is strattice lifecell recon perforate, 20cmx16cm. My abdominal pain is out of control and has been since date of surgery (b)(6) 2022. I have developed seroma, awful bowels, fatigue all with level 8-10 pains every day. Bilateral leg pains that have intensified since surgery. I have been to the er post surgery for pain. High reactive lymphocytes. Seen the surgeon a few times for help. None offered. Seen pain management doctor and my pcp. Will be talking with doctor for discussing mesh removal. This is inhumane on how i feel every day and being dismissed by the surgeon who put the mesh in. Fda safety report id # (b)(4).
 
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Brand NameSTRATTICE RECONSTRUCTIVE HENIA MESH
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL CORPORATION
MDR Report Key14469876
MDR Text Key292499450
Report NumberMW5109810
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 05/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Model Number1620002P
Device Catalogue Number1620002P
Device Lot NumberSP200223-043
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No Answer provided

Patient Treatment Data
Date Received: 05/20/2022 Patient Sequence Number: 1
Treatment
BALANCE OF NATURE; ESTRACE; GABAPENTIN ; MELATONIN ; NEXIUM 24; PROBIOTIC ; PROBIOTIC ; TIZANIDINE; TYLENOL PM
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