MAUDE Adverse Event Report: INTEGRA - ACELL(COLUMBIA) CYTAL WOUND MATRIX 1-LAYER 3 X 7 CM

Catalog Number WS0307

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

A physician reported in behalf of a patient a cytal wound matrix caused a parasitic infection.Additional information has been requested.

Manufacturer Narrative

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

Event Description

N/a.

Manufacturer Narrative

The cytal wound matrix 1 (ws0307) was not returned for evaluation; therefore, an evaluation of the device could not be performed.Lot number information has been provided; therefore, device history record (dhr) was reviewed, and no anomalies were found.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The device was used almost ten (10) years ago on the patient.And environmental conditions during and after the device application are not known.As the device used on the patient was completely resorbed many years ago, and all other devices in that particular lot number have been sold and used, no device return is available for examination.

• Brand Name: CYTAL WOUND MATRIX 1-LAYER 3 X 7 CM
• Type of Device: CYTAL
• Manufacturer (Section D): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; 6640 eli whitney drive; columbia MD
• Manufacturer (Section G): INTEGRA - ACELL(COLUMBIA); 6640 eli whitney drive; columbia MD
• Manufacturer Contact: vivian nelson ; 1100 campus drive; princeton, NJ ; 6099362319
• MDR Report Key: 13231989
• MDR Text Key: 288286750
• Report Number: 3005920706-2022-00001
• Device Sequence Number: 1
• Product Code: KGN
• Combination Product (y/n): N
• PMA/PMN Number: K152721
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: WS0307
• Device Lot Number: LS100-04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2022
• 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