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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BIOLOGIC TISSUE MATRIX: VIVIGEN FORMABLE SYRINGE, PISTON

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WRIGHTS LANE SYNTHES USA PRODUCTS LLC UNK - BIOLOGIC TISSUE MATRIX: VIVIGEN FORMABLE SYRINGE, PISTON Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 01/01/2021
Event Type  Injury  
Manufacturer Narrative
Additional narrative: event occurred on an unknown date in 2021. 510k: this report is for an unknown biologic tissue matrix: vivigen formable/unknown lot. Part and lot numbers are unknown; udi number is unknown. Complainant part is not expected to be returned for manufacturer review/investigation. Without a lot number the device history records review could not be completed. Product was not returned. Based on the information available, it has been determined that no corrective and/or preventative action is proposed. This complaint will be accounted for and monitored via post market surveillance activities. If additional information is made available, the investigation will be updated as applicable. Device was used for treatment, not diagnosis. If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported on (b)(6) 2021, the patient developed a sinus infection after being implanted with the unknown vivigen formable on an unknown date. The patient was treated by the physician with debridement and medication. The patient outcome is unknown. There is no further information available. This complaint is related to (b)(4). This report is for one (1) unk - biologic tissue matrix: vivigen formable. This is report 1 of 1 for (b)(4).
 
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Brand NameUNK - BIOLOGIC TISSUE MATRIX: VIVIGEN FORMABLE
Type of DeviceSYRINGE, PISTON
Manufacturer (Section D)
WRIGHTS LANE SYNTHES USA PRODUCTS LLC
1302 wrights lane east
west chester PA 19380
Manufacturer Contact
kara ditty-bovard
1302 wright lane east
west chester, PA 19380
6107195000
MDR Report Key13342115
MDR Text Key287274577
Report Number2939274-2022-00239
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 01/25/2022 Patient Sequence Number: 1
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