MAUDE Adverse Event Report: CALDERA MEDICAL DESARA BLUE TV; SURGICAL MESH

Model Number	CAL-DS01BTV
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	01/12/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The doctor reported that the patient required explant of desara blue tv sling six months post-op due to pain.The sling was implanted on (b)(6) 2020, and was explanted on (b)(6) 2021.No lot number was provided, and the product was not returned for evaluation.No further information was provided.Without additional information, it is unknown whether the adverse event occurred due to surgical techniques, patient pathology or other conditions.

• Brand Name: DESARA BLUE TV
• Common Device Name: SURGICAL MESH
• Manufacturer (Section D): CALDERA MEDICAL; 5171 clareton drive; agoura hills CA 91301
• Manufacturer (Section G): CALDERA MEDICAL; 5171 clareton drive; agoura hills 91301
• Manufacturer Contact: alicia heckathorne ; 5171 clareton drive; agoura hills, CA 91301 ; 8188796555
• MDR Report Key: 14274595
• Report Number: 3003990090-2021-01528
• Device Sequence Number: 5842661
• Product Code: OTN
• UDI-Device Identifier: 00890594000834
• UDI-Public: 00890594000834
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162201
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/21/2021

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
• Operator of Device: Health Professional
• Device Model Number: CAL-DS01BTV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 05/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female