MAUDE Adverse Event Report: TEI BIOSCIENCES INC SURGIMEND 3.0 16X20 CM

Catalog Number 606-300-008

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 05/03/2023

Event Type  Injury  

Event Description

A facility reported a surgimend (id (b)(6)) had adhered to the plung causing an accumulation of pus in the device.Surgimend could not be vascularize.It was very difficult for the surgeon to remove part of the surgimend.As per surgeon: "it was complicated because the prosthesis adhered strongly to the lung and to the periphery.I left a collar around the perimeter and when i cut the prosthesis with a scalpel, since it is impossible to use a scissors, i noticed that there was pus inside the prosthesis.The culture of these collections is positive." the surgeon states this event is due to the fragility of the patient and not related to the product.

Manufacturer Narrative

An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.

Manufacturer Narrative

Additional information received: "patient has negative pressure dressing for healing.This has an impact of their life quality".

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Follow-up - lot number provided, product id updated dhr - lot 2206017 (product id 606-300-008) no anomalies in the manufacturing process/dhr that could be correlated to the cause of this complaint.Root cause update - no root cause analysis could be completed/determined due to a lack of information provided and lack of returned product.Given the information provided by the complainant, the probable cause of the event is a mrsa infection, which is unrelated to the device.

• Brand Name: SURGIMEND 3.0 16X20 CM
• Type of Device: SURGIMEND
• Manufacturer (Section D): TEI BIOSCIENCES INC; 7 elkins street; 7 elkins street; boston MA
• Manufacturer (Section G): TEI BIOSCIENCES INC; 7 elkins street; boston MA
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 17037054
• MDR Text Key: 316284624
• Report Number: 3004170064-2023-00004
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• PMA/PMN Number: K083898
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 606-300-008
• Device Lot Number: 2206017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1