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

Catalog Number 1620002

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/16/2021

Event Type  Injury  

Manufacturer Narrative

As of 5/7/2021, of the (b)(4) devices released to finished goods for lot sp200180, (b)(4) have been distributed.Of the (b)(4) distributed, 43 have been reported as implanted.

Event Description

Patient was implanted with the strattice on (b)(6) 2021 and she immediately started to have complications.Chris then stated that the doctor went in to check the strattice and noticed it was torn in multiple places.The strattice was then explanted on (b)(6) 2021.

• Brand Name: STRATTICE RECONSTRUCTIVE TISSUE MATRIX, 16 X 20, FIRM
• Type of Device: MESH SURGICAL
• Manufacturer (Section D): LIFECELL; one millennium way; branchburg NJ
• Manufacturer (Section G): BRANCHBURG; one millennium way; branchburg NJ 08876
• Manufacturer Contact: chris belle ; one millennium way; branchburg, NJ ; 9089471470
• MDR Report Key: 11803618
• MDR Text Key: 249934214
• Report Number: 1000306051-2021-00038
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K070560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 1620002
• Device Lot Number: SP200180
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention