FDA Adverse Event Injury Summary report: N

DESARA BLUE TV

MDR report key: 9419630 · Received December 5, 2019

Report

Report Number: 3003990090-2019-01491
Event Type: Injury
Date Received: December 5, 2019
Report Date: December 3, 2019
Manufacturer: CALDERA MEDICAL INC.
Product Code: OTN
UDI-DI: 00890594000834
PMA / PMN Number: K1326069
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE SURGEON AND REP HAVE BEEN CONTACTED FOR FURTHER INFORMATION. DR. (B)(6) COULDN'T IDENTIFY SPECIFIC CAUSE OF THAT COULD HAVE CONTRIBUTED TO THE EXTRUSION AND THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THE LOT HISTORY RECORD FOR DESARA BLUE TV # K06022 SHOWS NO NON-CONFORMANCES OR DEVIATIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. THE PRODUCT WAS USED PRIOR TO ITS EXPIRATION DATE OF 06-20-2022. BASED UPON THE INFORMATION AS PRESENTED, IT IS UNKNOWN WHETHER THE ISSUE AS DESCRIBED IS RELATED TO THE DEVICE, PATIENT MEDICAL HISTORY, OR SURGICAL TECHNIQUE. MESH EROSION/EXPOSURE/EXPLANT IS A KNOWN RISK WITH THE USE OF ALL MESH PROCEDURES AND MAY BE DUE TO DEVICE MALFUNCTION, SURGICAL PROCEDURE, OR PATIENT MEDICAL HISTORY.

Description of Event or Problem · 1

SALES REP REPORTED THAT DR. (B)(6) PATIENT EXPERIENCED AN EXTRUSION USING DESARA BLUE TV. SURGEON JUST SUTURED UP THE EXTRUSION AND IS HOPING THAT WILL SOLVE THE PROBLEM. THE PATIENT WAS NOT EXPERIENCING ANY PAIN OR DISCOMFORT, ALTHOUGH DR. (B)(6) IS CONCERNED SHE MAY EXPERIENCE PAINFUL INTERCOURSE. HE IS GOING TO CONTINUE TO MONITOR HER AND IF NECESSARY HE WILL CUT OUT THE PIECE OF MESH THAT IS EXTRUDING.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1214466	DESARA BLUE TV	PELVIC MESH SLING	OTN	CALDERA MEDICAL INC.		K06022	00890594000834

Patients

Seq	Age	Sex	Outcome	Treatment
1			Hospitalization\| R