MAUDE MDR 9673934

MDR report key: 9673934
Report number: 2210968-2020-00967
Event key: 0
Event type: 3
Date received: 2020-02-05
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
Seq	Brand	Generic	Manufacturer	Product code	Model	Catalog	Lot	PMA	510(k)	Implant	Evaluated	Availability
1	MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT	SUTURE, ABSORBABLE, SYNTHETIC	ETHICON INC.	GAN							R	N

Patients#

Sequence, Received, Treatment table
Sequence	Received	Treatment	Outcome
1	2020-02-05	0	1. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL PATIENT EVENTS. IT IS UNKNOWN WHICH EVENT OCCURRED WITH WHICH SUTURE LAYER. PATIENT EVENT REACTION REGARDING PDS SUTURE CAPTURED IN MW 2210968-2020-00965; PATIENT EVENT REGARDING DEEP MONOCRYL CAPTURED IN MW 2210968-2020-00966; PATIENT EVENT REGARDING 2-0 MONOCRYL CAPTURED; PATIENT EVENT REGARDING 3-0 MONOCRYL CAPTURED IN MW 2210968-2020-00968; PATIENT EVENT REGARDING 4-0 MONOCRYL CAPTURED IN MW 2210968-2020-00969.

D

Patient 1

IT WAS REPORTED BY AN ATTORNEY THAT THE PATIENT UNDERWENT RIGHT IMMEDIATE BREAST RECONSTRUCTION USING A MUSCLE AND FASCIAL SPARING TRAM FLAP BASED ON THE DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR, LEFT IMMEDIATE BREAST RECONSTRUCTION USING A MUSCLE-SPARING TRAM FLAP BASED ON THE DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR ON (B)(6) 2009 DURING WHICH ?THE ABDOMINAL WOUND WAS THEN CLOSED USING 0 PDS SUTURES IN THE SCARPA?S, 2-0 MONOCRYL IN THE DEEP DERMIS AND 3-0 MONOCRYL RUNNING CUTANEOUS SUTURES. THE UMBILICUS WAS THEN FASHIONED TOWARDS THE MIDLINE AND SUTURES USING 4-0 MONOCRYL DEEP DERMAL SUTURES. THE FLAP WAS THEN INSET USING 3-0 DEEP DERMAL MONOCRYL AND 4-0 MONOCRYL SUBCUTICULAR SUTURES. THE WOUND WAS THEN INSET USING 3-0 MONOCRYL DEEP DERMAL SUTURES AND 4-0 MONOCRYL SUBCUTICULAR SUTURES.? IT WAS REPORTED THE PATIENT EXPERIENCED ?BROKEN SUTURES, OPENING OF THE WOUND, ABDOMINAL WOUND CARE, VAC- MACHINE FOR SUCTIONING, PAIN, SWELLING, PUS, BLEEDING, FROTHY DRAINING AND FEVER. AFTER THE SUTURE WAS REMOVED, PATIENT EXPERIENCED PERMANENT SCARS AND CONTINUES TO HAVE AN ALLERGIC INTERNAL REACTION TO THE SUTURE.? NO ADDITIONAL INFORMATION WAS PROVIDED.

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
10705031463998	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470354	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470361	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470385	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031470392	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
30705031470358	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
30705031470396	MONOCRYL	ETHICON, LLC	GAN	2023-08-28
10705031059764	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
10705031135017	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
10705031135024	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
10705031135031	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
30705031059768	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
30705031135028	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
30705031135035	MONOCRYL	ETHICON, LLC	GAN	2023-05-17
07757093001539	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001553	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001560	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001621	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001638	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001652	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001683	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001829	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001898	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001959	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001973	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093001997	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093002017	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093002093	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093002123	SUTUMED	Unilene S.A.C.	GAN	2023-01-09
07757093218449	SUTUMED	Unilene S.A.C.	GAN	2023-01-09

Type, Submission, Product code table
Type	Submission	Product code	Device	Applicant	Decision date
510(k)	K003015	GAN	SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD	Surgical Specialties Corp	2000-12-15
510(k)	K964072	GAN	MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED	ETHICON, Inc.	1996-12-18
510(k)	K960653	GAN	MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED)	ETHICON, Inc.	1996-03-28
510(k)	K951231	GAN	ORTHOPEDIC PACKS	Sterile Concepts, Inc.	1995-12-01
510(k)	K920978	GAN	ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED	ETHICON, Inc.	1994-02-15
PMA	N17472S043	GAN	VICRYL (POLYGLACTIN 910) SUTURE	ETHICON, Inc.	1987-10-05
PMA	N17472S042	GAN	VICRYL (POLYGLACTIN 910) SUTURE	ETHICON, Inc.	1987-08-28
PMA	N17482S035	GAN	VICRYL MESH	ETHICON, Inc.	1987-06-18
PMA	N17472S041	GAN	VICRYL (POLYGLACTIN 910) SUTURE	ETHICON, Inc.	1987-06-18
PMA	N17482S034	GAN	VICRYL MESH	ETHICON, Inc.	1986-12-03

MAUDE MDR 9673934

Related Records#

Manufacturer Contact#

Devices#

Patients#

Event Narratives#

N

D

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