MAUDE Adverse Event Report: AROA BIOSURGERY OVITEX REINFORCED BIOSCAFFOLD SURGICAL MESH

Catalog Number F10248-1822P

Device Problem Insufficient Information (3190)

Patient Problem Abscess (1690)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Despite repeated requests, no further details on the cause, location, or content of the abscess were obtained, nor any further information regarding the findings during the second surgery. Absent further information, no conclusions can be drawn. Based on documented experience with post-operative infections it is unlikely that the abscess caused the partial digestion of the implant. A dhr review was completed and no non-conformances or anomalies were found that may have caused or contributed to the event. (b)(4).

Event Description

A ventral hernia repair was performed with ovitex 2s p on (b)(6) 2019. It was reported that the patient developed an abscess a few weeks after surgery which did not resolve with percutaneous drains. The patient underwent a second surgery on approximately (b)(6) 2019 in which the implant was found partially digested. The surgeon removed the implant.

• Brand Name: OVITEX REINFORCED BIOSCAFFOLD
• Type of Device: SURGICAL MESH
• Manufacturer (Section D): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• Manufacturer (Section G): AROA BIOSURGERY; 2 kingsford smith place; airport oaks; auckland, 2022 ; NZ 2022
• Manufacturer Contact: john urtz ; 1 great valley parkway; suite 24; malvern, PA 19355 ; 4843202884
• MDR Report Key: 8683048
• MDR Text Key: 147470213
• Report Number: 3007321028-2019-00006
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153632
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial
• Report Date: 05/17/2019,06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 12/31/2019
• Device Catalogue Number: F10248-1822P
• Device Lot Number: ERT-8A07
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Distributor Facility Aware Date: 05/17/2019
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/17/2019
• Date Manufacturer Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2018
• 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: 06/10/2019 Patient Sequence Number: 1