• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL BPS STRATTICE 4 CM X 16 CM - PLIABLE MESH, SURGICAL

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

LIFECELL BPS STRATTICE 4 CM X 16 CM - PLIABLE MESH, SURGICAL Back to Search Results
Catalog Number 0416006
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Seroma (2069)
Event Date 12/15/2017
Event Type  Injury  
Manufacturer Narrative
The device was not returned to lifecell for evaluation as it was discarded. The internal investigation into lot sp100528 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 processing deviations or nonconformances related to the nature of this event. The lot was terminally sterilized within the process parameters and met all qc release criteria. To date, of the (b)(4) devices released to finished goods for lot sp100528, (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. Other surgical or patient factors could also contribute to this event. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported that a patient was implanted with strattice bps (lot number: sp100528) on (b)(6) 2017. In the months following the surgery, the patient experienced fluid accumulation surrounding the breast alternating from one side to the other. The surgeon advised they believed the fluid was an ¿inflammatory response due to the tissue never integrating into the skin. ¿ on (b)(6) 2019 the patient had the strattice explanted. The product has now been discarded and is not available for return.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBPS STRATTICE 4 CM X 16 CM - PLIABLE
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 Key8549304
MDR Text Key143393596
Report Number1000306051-2019-00068
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
PMA/PMN Number
K082176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2019
Device Catalogue Number0416006
Device Lot NumberSP100528
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/09/2017
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: 04/25/2019 Patient Sequence Number: 1
-
-