FDA.reportPublic FDA data

MAUDE MDR 9752246

MDR report key
9752246
Report number
2210968-2020-01471
Event key
0
Event type
3
Date of event
2020-01-01
Date received
2020-02-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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.GANY497GY497GR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-02-2501. 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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE PATIENT DEMOGRAPHIC INFO: AGE, GENDER, WEIGHT, BMI AT THE TIME OF INDEX PROCEDURE. DATE AND NAME OF THE INDEX SURGICAL PROCEDURE. CAN YOU CLARIFY THE LOT NUMBER USED? THE DIAGNOSIS AND INDICATION FOR THE INITIAL SURGICAL PROCEDURE? ON WHAT TISSUE WAS THE SUTURE USED? WHAT WAS THE TISSUE CONDITION, I.E., NORMAL OR THIN, CALCIFIED, FRAGILE, DISEASED? WHAT WAS THE ONSET DATE OF SYMPTOMS FROM THE INITIAL SURGICAL PROCEDURE? CAN YOU EXPLAIN WHAT IS MEANT BY ?TISSUE BEING EATEN AWAY?? DO YOU HAVE ANY PHOTOS FOR REVIEW? WAS MEDICAL INTERVENTION PERFORMED? IF YES, PLEASE DESCRIBE. WHAT WAS THE DATE OF THE SECOND PROCEDURE? CAN YOU DESCRIBE THE APPEARANCE OF THE SUTURE DURING THE SECOND PROCEDURE? WERE PRE, PERI OR POST- OPERATIVE ANTIBIOTICS PRESCRIBED? WHAT WAS THE INDICATION FOR PRESCRIBING ANTIBIOTICS? WERE CULTURES PERFORMED? IF SO, WHAT ARE THE RESULTS? OTHER RELEVANT PATIENT HISTORY/CONCOMITANT MEDICATIONS WHAT IS THE PHYSICIAN?S OPINION AS TO THE ETIOLOGY OF OR CONTRIBUTING FACTORS TO THIS EVENT? WHAT IS THE PATIENT?S CURRENT STATUS? THE LOT NUMBER OF MK5861 IS INVALID. CAN YOU PLEASE PROVIDE THE CORRECT LOT NUMBER?

D

Patient 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A PLASTIC SURGERY PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. POST OPERATIVE, THE PATIENT PRESENTED WITH SYMPTOMS OF THE TISSUE BEING EATEN AWAY AT THE INCISION SITE DUE TO A REACTION. THE PATIENT WAS TREATED WITH ORAL AND TOPICAL ANTIBIOTICS. IT WAS REPORTED THAT IT WAS POSSIBLE THE PATIENT'S INCISION HAD TO BE COMPLETELY REDONE. THE IMPLANT HAD TO BE REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.