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Model Number UNKNOWN
Device Problems Microbial Contamination of Device (2303); Device Contamination With Biological Material (2908)
Patient Problem Bacterial Infection (1735)
Event Date 01/05/2017
Event Type  Injury  
Manufacturer Narrative
Method of evaluation: actual device not evaluated. The device was not returned for evaluation. It was not specified if the device was explanted.
Event Description
No new information was reported.
Manufacturer Narrative
(b)(4). Method of evaluation: actual device not evaluated - the device was not returned for evaluation. It was not specified if the device was explanted along with the implant. The lot associated with this event remains unknown; therefore a review of the device history records could not be performed. Device not returned. Device failure related to patient condition. Based on the limited information, a relationship between the event and the strattice device could not be determined. The event is likely related to patient condition and unlikely related to strattice. As the literature review reveals, in 22 out of 23 of these cases, the wounds were considered at least contaminated prior to mesh closure. It should be noted that disintegration of the device is not a malfunction when the device is exposed to deleterious substances such as bacterial contamination, or interstitial fluids. Exposure of the device to these substances may be caused by iatrogenic injury, post operative complications, and co-morbid conditions unrelated to the device itself. If additional information is reported, a follow up report will be submitted.
Event Description
During a literature review performed on (b)(6) 2017, a publication titled "the biologic prosthesis is a viable option for abdominal wall reconstruction in pediatric high risk defects" reported that a retrospective chart review was performed of all cases of abdominal wall reconstruction in a single institution (children's hospital los angeles) between january 2007 - february 2015. Overall there were a total of 23 patients who underwent abdominal wall reconstruction using a biological prosthesis including 17 neonates (0-28 days old) and non-neonates (6wks to 19 years). In 22 cases, the wounds were considered at least contaminated or infected prior to mesh closure. This complaint is associated with patient #13 in table 1 of the article implanted with strattice. Patient #13 was(b)(6) with a diagnosis of omphalocele. Primary skin closure was not achieved following ab wall reconstruction with strattice. Complication reported was sloughed mesh and reherniation.
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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 Key6998894
MDR Text Key247165892
Report Number1000306051-2017-00083
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/05/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/03/2017
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 Received10/05/2017
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: 11/03/2017 Patient Sequence Number: 1