MAUDE Adverse Event Report: CALDERA MEDICAL, INC. CALDERA DESARA BLUE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number CALDS01BTV30

Patient Problems Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Nerve Damage (1979); Pain (1994); Burning Sensation (2146); Hot Flashes/Flushes (2153); Chills (2191); Discomfort (2330); Arthralgia (2355); Skin Inflammation/ Irritation (4545); Swelling/ Edema (4577)

Event Date 06/06/2023

Event Type  Injury  

Event Description

Mus w/ prolapse surgery: caldera desara blue mus awoke to pain scale of 10 in vagina in recovery-stabbing/severe poking feeling.Unable to sit in reclining position for two weeks post op.Slowly moved my way to a reclining position weeks after surgery.Never have been able to sit long w/o onset of burning, severe pain, swelling to pelvis, abdomen ¿ diagnosed with chronic pelvic pain post op ¿ allergic to propylene glycol (product of polypropylene) ¿ reacting allergically to all vaginal lubricants for pfpt, exam, estrogen creams ¿ chronic visual inflammation, irritation, w/ pressure in pelvis since surgery ¿ nerve-burning pain clitoris, urethra area pain runs to bladder ¿ burning during/after urination intermittently ¿ october, began intestinal spasming left side near c-section scar area w/ painful bladder ¿ vaginal bulge.Told it was the anterior vag wall.Protrudes when standing/walking.Feels like crowning w/ prolonged walking/standing.Hardness/painful when standing.Sitting-burns when getting up after sitting.Intermittent feeling of wanting to push/bear down to push it out.¿ on ic diet now.Cannot tolerate coffee, teas, ect.Feels like onset of cystitis if i consume these products.Abdominal swelling as well.Very painful ¿ poking/pinching when leaning forward.Pulling/pinching bending.Can happen while lying in bed w/o movement.Sudden stab of needle like pain at bladder or urethral area ¿ 24 hrs a day i feel a scratching feeling what feels like behind my clitoris/urethra against my bladder.Like a sand paper friction w/ tiny pin pricks feeling with every movement ¿ cannot touch the clitoris or area for long-painful.Would never be able to tolerate sex ¿ rectum swollen too.Having to lift buttocks up to support a bm ¿ hot then cold chills.Joints are more painful than usual.Dark circles under eyes have developed post op ¿ dx w/ recent bv infection.Ph high w/ odor.Doctor in virtual kp appt.Shared i should expect the infection to come back until mesh is removed.This has completely adversely affected my quality of life.Unable to sit without severe pain.Unable to enjoy anything because my body is in pain.I am allergic to pg, which is a product of polypropylene.Why is this being implanted into pts w/o testing if they are allergic to this polymer? surgeon was aware of all of these symptoms.Surgeon dismissed symptoms.This is unacceptable that women are suffering from this mesh, then, dismissed and misdiagnosed by same physician/s who saw their healthy pt before surgery.Yes, this is helpful for some women.But for those of us whom are reacting to the product, and/or suffering terrible, debilitating side effects of the procedure, to be denied by same treating physician that the mesh is the cause; this is disabling lives and quality of life.More must be done for advocation for women who suffer from this procedure.I am facing months of waiting to get into a specialist to have mesh removed.

• Brand Name: CALDERA DESARA BLUE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): CALDERA MEDICAL, INC.
• MDR Report Key: 18446387
• MDR Text Key: 332253546
• Report Number: MW5149774
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CALDS01BTV30
• Device Catalogue Number: SYSTEM TV SLING W/3.0MM INTROD
• Device Lot Number: N12027
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: FIBRIN A4YBF00101.; IMPLANT OF MUS ONLY.; USING POTASSIUM EVERY FOUR DAYS TO KEEP POTASSIUM UP UNTIL MESH REMOVED.; VITAMINS ONLY.
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Weight: 61 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White