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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL UNKNOWN STRATTICE MESH, SURGICAL

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LIFECELL UNKNOWN STRATTICE MESH, SURGICAL Back to Search Results
Catalog Number UNK STRATTICE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hernia (2240); Obstruction/Occlusion (2422); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 06/07/2019
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation and although a lot number was reported, the lot number is invalid and remains unknown; therefore, internal investigation could not be performed. Based on the reported information, a relationship between the event and strattice cannot be confirmed. If additional information is reported, a follow up adverse event report will be submitted. No further actions are required as a nonconformance could not be confirmed.
 
Event Description
It was reported that a (b)(6) year old female underwent hernia repair surgery on (b)(6) 2010 with dr. (b)(6) who preformed the incarcaerated hernia repair in (b)(6) and placed strattice lot s10693-287. After the surgery, the patient returned to the hospital on (b)(6) 2015 and was diagnosed with an incarcerated hernia recurrence with strangulated bowel. The surgeon placed a second piece of strattice - lot sp10069-167 and performed the revision surgery. The patient returned to the hospital on (b)(6) 2019 and was diagnosed with a small bowel obstruction and the strattice mesh was balled up on the edges requiring removal of the mesh. It was not reported if both lots were explanted. This complaint investigation is associated to lot sp10069-167.
 
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Brand NameUNKNOWN STRATTICE
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer (Section G)
LIFECELL
1 millennium way
branchburg NJ 08876
Manufacturer Contact
christopher belle
1 millennium way
branchburg, NJ 08876
9089471470
MDR Report Key12080571
MDR Text Key269384303
Report Number1000306051-2021-03010
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
Report Date 06/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK STRATTICE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2021
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: 06/28/2021 Patient Sequence Number: 1
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