MAUDE Adverse Event Report: COLLAGEN MATRIX, INC. ZIMMER COLLAGEN TAPE; PORCINE COLLAGEN DENTAL WOUND DRESSING - TAPE

Catalog Number 0100Z

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Hypersensitivity/Allergic reaction (1907); Discomfort (2330)

Event Type  Injury  

Event Description

Complaint received via phone from sales representative - the patient had an allergic reaction and wanted to report incident.No injury to patient reported.Symptoms: allergic reaction, irritation, and discomfort.

• Brand Name: ZIMMER COLLAGEN TAPE
• Type of Device: PORCINE COLLAGEN DENTAL WOUND DRESSING - TAPE
• Manufacturer (Section D): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer (Section G): COLLAGEN MATRIX, INC.; 15 thornton road; oakland NJ 07436
• Manufacturer Contact: peggy hansen ; 15 thornton road; oakland, NJ 07436
• MDR Report Key: 12146346
• MDR Text Key: 260934638
• Report Number: 2249852-2021-00009
• Device Sequence Number: 1
• Product Code: KGN
• Combination Product (y/n): N
• PMA/PMN Number: K122115
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial
• Report Date: 06/09/2021

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
• Device Operator: No Information
• Device Catalogue Number: 0100Z
• Initial Date Manufacturer Received: 06/09/2021
• Initial Date FDA Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other