MAUDE Adverse Event Report: CALDERA MEDICAL INC. "TVT-CAL-ABDOMINAL; TVT W/ABDOMINAL GUIDES

Model Number	810041A
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An investigation could not be performed as the device is not returned.Based on the limited information provided, the reported product complaint could not be confirmed.A review of general manufacturing records indicates that all products released during the relevant timeframe were manufactured in accordance with approved procedures and met established specifications during the manufacturing and quality release process.Based on the information available, no further action is required at this time.
Event or Problem Description
"wcq received an e-mail from the ethicon risk manager team stating the following: it was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and tvt was implanted.It was reported that the patient experienced an unknown adverse event.No additional information was reported.".
Event or Problem Description
It was reported that the patient underwent a gynecological surgical procedure on (b)(6) 2008 and tvt was implanted.It was reported that the patient experienced an unknown adverse event.No additional information was reported.
Additional Manufacturer Narrative
Additional information: a3, b5, e3, g4, h5, h6, h11.Correction: b5, e1, g2.Investigation results: product was not returned.Based on the information available, no further action is required at this time.Complaint information is trended on a regular basis to determine if further investigation is warranted.If additional information is made available, the investigation will be updated as applicable.The manufacturing number is c25-2856.

• Brand Name: "TVT-CAL-ABDOMINAL
• Common Device Name: TVT W/ABDOMINAL GUIDES
• Manufacturer (Section D): CALDERA MEDICAL INC.; 4360 park terrace dr. suite140; westlake village CA 91361
• Manufacturer (Section G): CALDERA MEDICAL SARL-NEUCHATEL; puits-godet 20; neuchatel 2000, ; SZ
• Manufacturer Contact: mahtab moberg ; 4360 park terrace dr. suite 140; westlake village, CA 91361
• MDR Report Key: 23297406
• Report Number: 3003990090-2025-01638
• Device Sequence Number: 4890158
• Product Code: OTN
• UDI-Device Identifier: 10705031062283
• UDI-Public: 10705031062283
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K173162
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2008
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Operator of Device: Health Professional
• Device Model Number: 810041A
• Device Lot Number: 3182097
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female