MAUDE Adverse Event Report: ALLIED HEALTHCARE PRODUCTS, INC. GROMCO; CLAMP, CIRCUMCISION

Device Problems Failure to Form Staple (2579); Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/26/2018

Event Type  malfunction  

Event Description

Male infant undergoing circumcision with gromco 1.1 cm clamp.According to the physician, the device did not appear to crimp down enough to "seal" foreskin, causing more bleeding than normal.Additional pressure to the site and monitoring to ensure hemostasis.Infant did not have a prolonged stay and was discharged without complication.

• Brand Name: GROMCO
• Type of Device: CLAMP, CIRCUMCISION
• Manufacturer (Section D): ALLIED HEALTHCARE PRODUCTS, INC.; 1720 sublette ave.; saint louis MO 63110
• MDR Report Key: 7634160
• MDR Text Key: 112218580
• Report Number: 7634160
• Device Sequence Number: 1
• Product Code: HFX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2018
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 3