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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM MESH, SURGICAL

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STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM MESH, SURGICAL Back to Search Results
Catalog Number 1620002
Device Problem Patient-Device Incompatibility (2682)
Patient Problem Hernia (2240)
Event Date 05/29/2018
Event Type  Injury  
Manufacturer Narrative
A investigation into lot sp100409 resulted in no remarkable findings with one unrelated processing deviations and one unrelated nonconformance's revealed. As of 7/21/21, of the (b)(4) devices released to finished goods for lot sp100409, (b)(4) have been distributed. Of the (b)(4) distributed, (b)(4) have been reported as implanted. One other complaint reported against the lot. Lot sp100409 was terminally sterilized and met all qc release criteria.
 
Event Description
It was reported that (b)(6) year old male patient underwent hernia repair surgery on (b)(6) 2016 at (b)(6) hospital, (b)(6) and was implanted with strattice lot sp100409-083. The patient returned to the hospital on (b)(6) 2018 and had debridement of the necrotic abdominal wall including previously placed biological mesh, skin, subcutaneous tissue and muscle. On (b)(6) 2018, the patient underwent a laparotomy wound washout revision closure of the ventral hernia.
 
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Brand NameSTRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
Type of DeviceMESH, SURGICAL
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12212105
MDR Text Key262985361
Report Number1000306051-2021-03042
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
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1620002
Device Lot NumberSP100409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/01/2021
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: 07/22/2021 Patient Sequence Number: 1
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