MAUDE Adverse Event Report: ALAFAIR BIOSCIENCES VERSAWRAP; TENDON / NERVE PROTECTOR

Model Number	VTP-2201
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	08/07/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation into this feedback included 1) a review of the feedback details, 2) a review of the device lot history record, 3) a review of the complaint database, 4) communication with the surgeon and distributor, and 5) a review of the ifu.No anomalies were found, the root cause of the infection is unlikely related to versawrap.
Event or Problem Description
On (b)(6) 2023, using a da vinci system, a peritonectomy was performed.Versawrap was applied to the raw surfaces where the peritoneum was removed.Amniofix (mimedx) was also used in the procedure.Two (2) weeks postoperative the patient presented with fever and pain.Mri identified fluid near the fallopian tube.The patient was treated with oral antibiotics.A review of the device lot history records indicated the device was manufactured to specifications.The device is provided to the end user as a sterile device.The device would not cause an infection.Alafair biosciences has a validated sterilization cycle with a sterility assurance level of (sal) 10^-6.The validated sterility cycle and all parameters of all devices are verified prior to release for distribution.The root cause of the presence of a pelvic abscess is inconclusive.In a subsequent conversations with the surgeon, the surgeon indicated that the patient recovered and is doing well.

• Brand Name: VERSAWRAP
• Common Device Name: TENDON / NERVE PROTECTOR
• Manufacturer (Section D): ALAFAIR BIOSCIENCES; 6101 west courtyard dr; ste 1-225; austin TX 78730
• Manufacturer Contact: sarah mayes ; 6101 west courtyard dr.; ste 1-225; austin, TX 78730 ; 5127999627
• MDR Report Key: 17845456
• Report Number: 3012669262-2023-00003
• Device Sequence Number: 7247597
• Product Code: FTM
• UDI-Device Identifier: B454VTP22010
• UDI-Public: +B454VTP22010/$$5251230013096411001G
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K213163
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2025
• Device Model Number: VTP-2201
• Device Catalogue Number: VTP-2201
• Device Lot Number: 001309641-1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 09/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMNIOFIX
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 42 YR
• Patient Sex: Female
• Patient Weight: 68 KG