FDA.reportPublic FDA data

MAUDE MDR 9795562

MDR report key
9795562
Report number
2210968-2020-01723
Event key
0
Event type
3
Date of event
2019-12-29
Date received
2020-03-05
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
1MCRYL UD 18IN 3-0 S/A PS-2 PRM MPSUTURE, ABSORBABLE, SYNTHETICETHICON INC.GANY497GY497GMK6851R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-0501. R

Event Narratives#

N

Patient 1

(B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: ON WHAT TISSUE WAS THE SUTURE USED? SKIN&SUBCUTANEOUS. WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? NORMAL. WHAT SKIN PREP WAS USED ON THE PATIENT? HIBCLENS. WERE THERE ANY CHANGES IN SKIN PREP? NO CHANGE. HOW WAS THE SUTURE PLACED (INTERRUPTED OR CONTINUOUS)? BOTH. WHAT WAS USED TO CLOSE THE SKIN. 3-0 MONOCRYL. DID ONLY ONE BREAST EXPERIENCE THE REACTION/ DEHISCENCE? IF SO, WHICH SIDE? RIGHT. CAN YOU DESCRIBE THE AMOUNT (IN CM) OF DEHISCENCE/ OPENING? 5CM. WAS ANY MEDICAL INTERVENTION PERFORMED WHEN PATIENT RETURNED 12/29/2019 WITH SYMPTOMS? YES. WAS MEDICAL INTERVENTION PERFORMED? IF YES, PLEASE DESCRIBE. TOTAL RESECTION OF THE AREA AND RESUTURED. CAN YOU DESCRIBE THE APPEARANCE OF THE MONOCRYL SUTURE DURING THE SECOND PROCEDURE ON (B)(6) 2020? LOOKED NORMAL. DO YOU HAVE ANY PHOTOS OF THE REACTION FOR EVALUATION? NO. CAN YOU DESCRIBE THE APPEARANCE OF THE MONOCRYL SUTURE DURING PROCEDURE ON (B)(6) 2020? ABSENT. OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS. THE INCISION WAS PAPER THIN AFTER THE REACTION TO SUTURES. THIS WAS TWO MONTHS FOLLOWING BREAST AUGMENTATION. WHAT IS THE PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? PROBABLY IMPROPER STERILIZATION OF THE PRODUCT. WHAT IS THE PATIENT?S CURRENT STATUS? HEALED. THE FOLLOWING INFORMATION WAS REQUESTED BUT UNAVAILABLE: THE PATIENT DEMOGRAPHIC INFO: WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE.

D

Patient 1

IT WAS REPORTED THAT THE PATIENT UNDERWENT BREAST AUGMENTATION AND CRESCENT NIPPLE LIFT ON (B)(6) 2019 AND SUTURE WAS USED TO CLOSE THE INCISION. IT WAS REPORTED THAT THE SUTURE WAS USED ON THE SKIN AND SUBCUTANEOUS TISSUE AND PLACED INTERRUPTED AND CONTINUOUS. THE PATIENT RETURNED ON (B)(6) 2019 WITH DARKNESS ALONG THE INCISION LINE, BURNING, PAIN AND 5CM WOUND DEHISCENCE ON THE RIGHT BREAST. THE PATIENT UNDERWENT TOTAL RESECTION OF THE AREA AND RESUTURING. THE PATIENT'S TISSUE WAS REPORTED AS PAPER-THIN. ADDITIONAL INFORMATION WAS REQUESTED.