FDA.reportPublic FDA data

MAUDE MDR 9867817

MDR report key
9867817
Report number
2210968-2020-02293
Event key
0
Event type
3
Date of event
2014-01-17
Date received
2020-03-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
KARA DITTY-BOVARD
Address
P.O. BOX 151, ROUTE 22 WEST SOMERVILLE NJ 08876 US
Phone
610-610-6107
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GYNECARE TVT OBTURATORMESH, SURGICAL, SYNTHETIC, UROGYNECOLOGICETHICON INC.OTN8100818100813560734R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-2301. R

Event Narratives#

N

Patient 1

(B)(4). A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. ATTEMPTS ARE BEING MADE TO OBTAIN A DEVICE FOR EVALUATION. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: INDICATION FOR (B)(6) 2012 INITIAL SURGICAL PROCEDURE? YES. WERE ANY CONCOMITANT PROCEDURES PERFORMED? LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY AT TIME OF TVT-O (B)(6) 2012. WHAT MEDICAL INTERVENTION WAS GIVEN FOR THE PAIN MANAGEMENT? RESULTS? CURRENTLY SEEING NAMBOUR PAIN SERVICE. WHAT WAS AN INDICATION/DIAGNOSTIC CONFIRMATION FOR COMPLETE MESH EXCISION? CHRONIC PELVIC PAIN. SURGICAL FINDINGS OF (B)(6) 2020 MESH EXCISION PROCEDURE? NO MESH EXPOSURE IN VAGINA; NO MESH EROSION IN BLADDER OR URETHRA. WHAT IS PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? UNCERTAIN. WHAT IS THE PATIENT'S CURRENT STATUS? STILL SEEING PAIN SERVICE FOR MANAGEMENT. WAS PAIN AND DYSPAREUNIA RESOLVED AFTER MESH EXCISION? HAS NOT HAD FOLLOW UP YET WITH OUR SERVICE BUT IS STILL SEEING PAIN SERVICE FOR PAIN MANAGEMENT. AS PATIENT UNDERWENT COMPLETE EXCISION TVT-O RECENTLY ON (B)(6) 2020, JJM WOULD LIKE TO CONFIRM IF THERE IS ANY PRODUCT AVAILABLE FOR COLLECTION TO BE SENT BACK FOR EVALUATION? ALL PRODUCT IS AT THE HOSPITAL LAB FOR PROCESSING.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC LEFT SALPINGO-OOPHORECTOMY PROCEDURE ON (B)(6) 2012 AND THE MESH WAS IMPLANTED. THE PATIENT EXPERIENCED A LOWER ABDOMINAL PAIN AND DYSPAREUNIA OCCURRED 1-2 YEARS FOLLOWING INSERTION OF MESH. THE PATIENT UNDERWENT A COMPLETE EXCISION OF MESH ON (B)(6) 2020 DUE TO CHRONIC PELVIC PAIN. THERE WERE NO MESH EXPOSURE IN VAGINA AND NO MESH EROSION IN BLADDER OR URETHRA FOUND DURING MESH EXCISION. CURRENTLY, THE PATIENT HAS NOT HAD FOLLOW UP YET WITH OUR SERVICE BUT IS STILL SEEING PAIN SERVICE FOR PAIN MANAGEMENT.