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Model Number UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Hematoma (1884)
Event Date 07/25/2016
Event Type  Injury  
Manufacturer Narrative
This is a follow up #1 to report the investigation conclusion and the institution information. Lifecell has made multiple attempts to gather additional information from the investigator; however no additional information has been received to date, including the relevant lot number(s). The lot associated with this event remains unknown; therefore a review of the device history records cannot be performed. As per the risk management file for porcine tissue, it is concluded that hematoma is not caused by porcine tissue surgical mesh. Due to the lack of relevant clinical information and without an associated lot number, no relationship to the device can be determined. As reported in dr. (b)(6)'s abstract, it was concluded that there was no statistical difference regarding overall complications between the study arms. It should also be noted that while dr. (b)(6)'s assessment of the device relationship was "possibly," he reported that he couldn't say with certainty either way. As per the ifu, potential adverse events are those typically associated with surgical mesh materials and/or their implantation procedures including, but not limited to, hematoma.
Event Description
A study abstract published by the site investigator, dr. (b)(6), was reviewed. The abstract reported that this was a randomized multicenter trial primarily in (b)(6) and one site in the (b)(6) with women who had breast cancer planned for immediate ibbr. Subjects were randomly allocated with an adm (strattice) and partial muscle coverage or complete muscle coverage without adm. There were a total of 60 subjects in each arm. The study concluded in (b)(4) 2017. No additional information specific to this event was identified in the abstract.
Manufacturer Narrative
(b)(4). The lot associated with this event is unknown; therefore a review of the device history record cannot be performed. Lifecell is attempting to gather patient and procedure specific information including the lot number and device disposition and will be included in a follow up report.
Event Description
Subject (b)(6) is a female, as part of the investigator initiated clinical study (lohmander - immediate breast reconstruction with or without the use of acellular dermal matrix (strattice tm) - a randomized controlled trial). This is not a lifecell sponsored study. It was reported that subject (b)(6) was implanted with a strattice pliable device (implant date and lot number not reported) and developed a hematoma (sae start date: (b)(6) 2016) that was evacuated in the or. Sae outcome was reported as "resolved. " as the manufacturer, lifecell is reporting this event due to the investigator's assessment that the serious adverse event is possibly related to the study device.
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Manufacturer (Section D)
one millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
one millennium way
branchburg, NJ 08876
MDR Report Key6969605
MDR Text Key247166151
Report Number1000306051-2017-00080
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,study
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Catalogue NumberN/A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/26/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/23/2017 Patient Sequence Number: 1