MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION CIRCUMCISION TRAY

Model Number CIT5470

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Swelling (2091)

Event Date 11/14/2015

Event Type  malfunction  

Event Description

Infant with circumcision complication of "oozing" and "denuding of skin".Slit made in foreskin base, had tiny adhesions - these were cleared; folding back of foreskin over clamp (outer layer separated from mucus membrane) when i took off the clamp, left side of penile shaft was denuded.Gelfoam was applied - next day the neonatal np stated swelling down considerably and circumcision site looked much better.

• Brand Name: CIRCUMCISION TRAY
• Type of Device: CIRCUMCISION TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 100 centurion way; williamston MI 48895
• MDR Report Key: 5362883
• MDR Text Key: 35819185
• Report Number: 5362883
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/07/2016

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: Nurse
• Device Model Number: CIT5470
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/07/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1