MAUDE Adverse Event Report: MERZ NORTH AMERICA, INC. COAPTITE INJECTABLE IMPLANT

Catalog Number 8005P10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Sepsis (2067); Vomiting (2144); Chills (2191); Complaint, Ill-Defined (2331); Hematuria (2558)

Event Date 03/27/2015

Event Type  Injury  

Event Description

Initially this event was reported to a boston scientific (bsc) sales rep on (b)(6) 2015 with the following: the pt had coaptite bulking injection.Immediately post procedure, the patient was noted to be very sick, had an episode of vomiting, unreported diabetes and got sepsis.No treatment info was provided.On (b)(6) 2015, bsc noted that the date of injection was (b)(6) 2015.On (b)(6) 2015, the bsc sales rep noted that 2 separate coaptite syringes were used with a sidekick needle during the procedure.The injecting physician was contacted by boston scientific and on (b)(6) 2015 updated/further info was provided.The day of the procedure was (b)(6) 2015.The physician reported that several weeks ago she did a coaptite injection (1 syringe full) on a woman she had been following for mixed incontinence and prolapse.She had removed the pt's pessary a month before the injection.At that time the doctor had noted the pt had glycosuria of > 2000.He ordered a hgba1c and glucose on the pt and suggested she see her primary.The hgba1c was 14.The pt did not see her primary doctor.Post coaptite procedure, the pt was able to void before leaving office.After the pt left the office she immediately started vomiting and had chills.The pt went to the er.She was afebrile, had blood in her urine, an elevated white count with a bandemia and a glucose of >500.She was admitted and her diabetes was treated.Per dr.(b)(6), all cultures were negative through she does not know if a urine culture was obtained.At er - hematuria identified; (noted, common cause from coaptite injection).A uti ct scan was performed on the pt's abdomen.The pt has subsequently been discharged.She has followed up dr.(b)(6) at the end of last week.She had no glycosuria and her urine was clear.She still has some urge leakage but no sui.There is no evidence of any periurethral swelling, pain or tenderness which is what one would expect if the coaptite was infected, either primarily or by injection while the pt had bacteriuria.

Manufacturer Narrative

The pt told the doctor that she did not link her subsequent symptoms to the injection.The doctor also feels that the two events are not linked.

• Brand Name: COAPTITE INJECTABLE IMPLANT
• Type of Device: INJECTABLE IMPLANT
• Manufacturer (Section D): MERZ NORTH AMERICA, INC.; franksville WI
• Manufacturer Contact: a metz ; 4133 courtney road; suite 10; franksville, WI 53126 ; 2628353300
• MDR Report Key: 4740159
• MDR Text Key: 5890036
• Report Number: 2135225-2015-00026
• Device Sequence Number: 1
• Product Code: LNM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 8005P10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: KNOWN; .5ML LIDOCAINE UTILIZED BUT NO REACTION TO THIS
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR