FDA.reportPublic FDA data

MAUDE MDR 9621975

MDR report key
9621975
Report number
1018233-2020-00491
Event key
0
Event type
3
Date received
2020-01-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
3
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ANGELA ROBINSON
Address
8195 INDUSTRIAL BLVD COVINGTON GA 30014 US
Phone
770-770-7707
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ALYTE Y-MESH GRAFTALYTE Y-MESH GRAFTC.R. BARD, INC. (COVINGTON) -1018233OTOY100Y100HUVD1365R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-01-2301. R

Event Narratives#

N

Patient 1

THE SAMPLE WAS NOT RETURNED. THE FINISHED PRODUCT MET ALL SPECIFICATIONS PRIOR TO BEING RELEASED FOR GENERAL DISTRIBUTION. THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES ALL DEVICES CURRENTLY ADDRESSES POTENTIAL RISKS ASSOCIATED WITH SURGICALLY IMPLANTED MATERIALS. THE INSTRUCTIONS FOR USE STATES IN THE ADVERSE EVENTS: ?COMPLICATIONS ASSOCIATED WITH THE PROPER IMPLANTATION OF THE ALYTE? Y-MESH GRAFT MAY INCLUDE, BUT ARE NOT LIMITED TO THOSE TYPICALLY ASSOCIATED WITH SURGICALLY IMPLANTABLE MATERIALS INCLUDING: POSTOPERATIVE HEMATOMA, SEROMA, ABSCESS OR FISTULA FORMATION, OR SCARRING WHICH MAY OCCUR FOLLOWING THE IMPLANT PROCEDURE. URINARY RETENTION, BLADDER OUTLET OBSTRUCTION AND OTHER VOIDING AND DEFECATORY DYSFUNCTIONS. THESE CONDITIONS MAY BE ASSOCIATED WITH OVER-CORRECTION/TOO MUCH TENSION PLACED ON THE IMPLANT. PERFORATIONS OR LACERATIONS OF VESSELS, NERVES, BLADDER, BOWEL, URETHRA, RECTUM, OR ANY VISCERA, WHICH MAY OCCUR DURING THE IMPLANTATION PROCEDURE. IRRITATION AT THE OPERATIVE WOUND SITE WHICH MAY ELICIT A FOREIGN BODY RESPONSE THAT LEADS TO WOUND DEHISCENCE, INFLAMMATION AND/OR INFECTION. EXTRUSION THROUGH VAGINAL EPITHELIUM OR EROSION INTO SURROUNDING VISCERA AND/OR MUCOSA. INFLAMMATION, SENSITIZATION, PAIN, DYSPAREUNIA, SCARIFICATION, CONTRACTION, DEVICE MIGRATION AND FAILURE OF THE PROCEDURE RESULTING IN RECURRENCE OF VAGINAL WALL PROLAPSE. URINARY INCONTINENCE (STRESS AND URGE)." (B)(4). SAMPLE NOT RECEIVED.

D

Patient 1

PER ADDITIONAL INFORMATION RECEIVED VIA MEDICAL RECORDS THE PATIENT HAS EXPERIENCED RECURRENT PELVIC PROLAPSE (ENTEROCELE AND RECTOCELE), VAGINAL MESH EROSION, PELVIC PAIN AND PRESSURE, VAGINAL BULGE, EXCISION OF MESH, VENTRAL HERNIA REPAIR WITH MESH, RECURRENT PELVIC ORGAN PROLAPSE (VAGINAL VAULT AND POSTERIOR COMPARTMENT), PLACEMENT OF A 2.5 X 10 CM SOFT POLYPROPYLENE MESH, ADHESIONS, EXPLORATORY LAPAROTOMY, TRANSABDOMINAL COLPOPEXY, MESH INCISED AND FASCIAL SCREWS FROM PRIOR VENTRAL HERNIA REPAIR REMOVED. SHE HAS REQUIRED THREE SURGICAL INTERVENTIONS.