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	08/03/2023
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 pain.Mri identified a 30 cm abscess in the lower left pelvis.Culture was negative.The patient was drained, requiring a one-week stay in the hospital.The patient was treated with iv antibiotics and prescribed a 6 week treatment of 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 conversation with the surgeon, the surgeon indicated that the patient is doing well and improving; as of (b)(6) 2023 the patient has one week remaining of a 6-week course of antibiotics.

• 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: 17845527
• Report Number: 3012669262-2023-00002
• Device Sequence Number: 17221605
• 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: 22 YR
• Patient Sex: Female
• Patient Weight: 68 KG