MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; DBD-CIRCLAMP W/1.3CM BELL ST - REPROCESS

Catalog Number	330CRK
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Genital Bleeding (4507)
Date of Event	06/07/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Increased bleeding.
Additional Manufacturer Narrative
It was reported that the patient experienced bleeding that required surgicell to acheive hemostasis."infant discharged home later same day as procedure".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Common Device Name: DBD-CIRCLAMP W/1.3CM BELL ST - REPROCESS
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico, s. de r.l; mexicali, baja california 21397 ; MX 21397
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19690456
• Report Number: 3004519921-2024-00031
• Device Sequence Number: 15238146
• Product Code: HFX
• UDI-Device Identifier: 10653160309901
• UDI-Public: 10653160309901
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/08/2024

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 Catalogue Number: 330CRK
• Device Lot Number: 2024020890
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown