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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE SURGICAL MESH

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LIFECELL CORPORATION STRATTICE SURGICAL MESH Back to Search Results
Model Number 1016001EU
Device Problem Radiation Overexposure (3017)
Patient Problems Inflammation (1932); Irritation (1941)
Event Type  Injury  
Manufacturer Narrative
(b)(4). Review of information as reported to lifecell. Review of the device history record for lot s11272. (b)(4). Qa investigation into lot s11272 resulted in no remarkable findings with no deviations or nonconformances revealed during processing with impact to product or patient safety. Although one similar complaint was reported against the lot, the physician did not attribute the event to the strattice. As of 12/29/2016, (b)(4) devices have been distributed. Lot s11272 met all qc release criteria. (b)(4). Based on the reported information, a relationship between the subject's right breast induration and the strattice cannot be determined by lifecell. Qa investigation resulted in no remarkable findings. Lot s11272 met all qc release criteria. This sae is being reported to both (b)(6) and the fda due to the investigator's assessment of the event relationship as certainly related to the strattice. It should be noted that the investigator has also assessed this event to be likely related to the radiotherapy. Device not returned to manufacturer.
 
Event Description
Subject #1 is a (b)(6) female, as part of the investigator initiated clinical study (rouanet/ protocol: isis), who underwent breast reconstruction on (b)(6) 2013 with a breast implant and strattice lot s11272-442. This is not a lifecell sponsored study. The following event was reported to lifecell by the study site contact on december 07, 2016: it was reported that subject 1 developed a periprosthetic induration (increase in fibrous tissue associated with inflammation) which was "annoying" on the right side of the irradiated prosthesis (onset date not reported). On june 7, 2016, the surgeon suggested removing the prosthesis. The patient was reported to be embarrassed by her reconstructed breast which is hard further to the radiotherapy. Both the strattice and breast implant were explanted from the right breast on (b)(6) 2016. Subject has recovered without sequelae. The investigator assessed the relationship as: possibly related to surgery, likely related to radiotherapy and certainly related to strattice. The subject's past medical history includes chemotherapy from (b)(6) 2013 and 3d radiotherapy in the right breast from (b)(6) 2014. As the manufacturer, lifecell is reporting this event due to the investigator's assessment that the serious adverse event is certainly related to the study device.
 
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Brand NameSTRATTICE
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
LIFECELL CORPORATION
one millennium way
branchburg NJ 08876
Manufacturer Contact
paul arrendell
one millennium way
branchburg, NJ 08876
9089471110
MDR Report Key6223780
MDR Text Key63917573
Report Number1000306051-2016-00088
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,s
Reporter Occupation
Type of Report Initial
Report Date 01/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/30/2015
Device Model Number1016001EU
Device Catalogue NumberN/A
Device Lot NumberS11272
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 Received12/07/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/07/2013
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: 01/04/2017 Patient Sequence Number: 1
Treatment
ALLERGAN BREAST IMPLANTS
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