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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL STRATTICE LAPAROSCOPIC 6CM X 8CM MESH, SURGICAL

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LIFECELL STRATTICE LAPAROSCOPIC 6CM X 8CM MESH, SURGICAL Back to Search Results
Catalog Number 0608005
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422)
Event Date 10/15/2016
Event Type  Injury  
Manufacturer Narrative
The device was not returned to lifecell for evaluation. The internal investigation into strattice lot: sp100317 included a review of the reported information, review of the device history records and review of the complaint history records. Investigation results revealed no remarkable findings with no similar complaints reported against the lot and no related deviations or nonconformances revealed during processing. The lot was terminally sterilized within the process parameters and met all qc release criteria including mechanical testing. To date, of the (b)(4) devices released to finished goods for lot: sp100317, (b)(4) have been distributed. Based on our internal review with no remarkable findings, a relationship to the strattice device and this event could not be determined. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported through voluntary mw5085057 that a patient underwent emergency paraesophageal hiatal hernia repair with stattice on (b)(6) 2016. The patient reported that following this surgery they have had the following complications and have been hospitalized numerous times: inability to swallow, severe abdominal pain, small bowel obstruction confirmed by ct scan, recurrence of paraesophageal hernia "due to mesh failure". The patient was brought back to the er where they were advised to have the mesh removed and to not use another mesh going forward to correct their hernia. The patient underwent revision surgery on (b)(6) 2019.
 
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Brand NameSTRATTICE LAPAROSCOPIC 6CM X 8CM
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471100
MDR Report Key8503764
MDR Text Key141595184
Report Number1000306051-2019-00066
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K130817
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Catalogue Number0608005
Device Lot NumberSP100317
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/02/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/11/2019 Patient Sequence Number: 1
Treatment
NO INFORMATION
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