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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 2540002
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Bacterial Infection (1735); Necrosis (1971)
Event Date 01/15/2015
Event Type  Injury  
Manufacturer Narrative
This legal event is being reported as serious injury due to the reported complications with surgical intervention. The lot associated with this event was not reported and remains unknown; therefore a review of the device history records could not be performed. No strattice devices were returned for evaluation. Based on the limited information reported, a relationship between the event and strattice cannot be confirmed. Due to the legal process, if additional information is made available during legal proceedings, a supplemental report will be submitted.
 
Event Description
It was reported through a legal event that a (b)(6) year old female patient had ventral incisional hernia repair surgery on or about (b)(6) 2014. During the hernia repair surgery, the surgeon implanted a strattice mesh. After surgery, the patient returned to the hospital on or about (b)(6) 2015 and was diagnosed with ischemic necrosis of the central portion of her midline incision. On or about (b)(6) 2015, the patient underwent the excision and debridement of an open abdominal wound. On or about (b)(6) 2015, the patient underwent abdominal wall debridement with wound vac placement. The strattice mesh was noted to have separated from the healing tissue and was incised. The patient presented several more times throughout 2015 for treatment of abdominal wall pain, wound infection, and dehiscence, and underwent additional excisional debridement of abdominal wound.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 25 X 40, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key13845499
MDR Text Key287596039
Report Number1000306051-2022-00042
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number2540002
Device Lot NumberSP100130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received09/14/2022
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: 03/22/2022 Patient Sequence Number: 1
Treatment
NO INFORMATION REPORTED
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