MAUDE Adverse Event Report: ETHICON INC. MCRYL+ UD 36IN 2-0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP945H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypovolemic Shock (1917); Blood Loss (2597); Not Applicable (3189)
Date of Event	05/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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.Attempts are being made to obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.What was the condition of the tissue where monocryl plus suture was used (normal, diseased, weakened)? how was the monocryl plus suture placed (interrupted or continuous)? were any knots found intact of the monocryl plus suture? what is the surgeon opinion of contributing factors to increased absorption? what is the surgeon opinion regarding the 1500ml blood in the abdomen? what does the surgeon believe caused/ contributed to the bleeding? what are the patient age, weight, prior medical conditions? you provided 2 lots of suture, can you identify which lot was used on the patient? what is the current condition of the patient?.
Event or Problem Description
It was reported that the patient underwent a laparotomy myomectomy procedure on (b)(6) 2018 and the suture was used on serosal layers of the uterus when multiple uterine incisions closed in standard fashion.During the procedure, fibroids were taken out.The procedure concluded without complications.It was also reported that the patient subsequently became unstable, went into hypovolemic shock and required return to operating room on (b)(6) 2018 for exploratory laparotomy.Upon inspection of the abdomen, the suture was missing on the uterus; not even scraps of suture were seen.Upon reentry, there was 1500 ml of blood in the abdomen.It was not noted how the case was completed.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to fda: (b)(4) 2018.Additional information was requested and the following was obtained: what was the condition of the tissue where monocryl plus suture was used (normal, diseased, weakened)? - normal.How the monocryl plus suture was placed (interrupted or continuous)? - continuous.Were any knots found intact of the monocryl plus suture? i was told that there was no monocryl at all seen when the abdomen was reopened and later told that there was one small scrap that was free floating in the abdomen.What is the surgeon opinion of contributing factors to increased absorption? - i placed three sheets of surgicel and 1 sheet of intercede on top of the uterus.I have never had this reaction before but was concerned that there might be an unknown cross reaction from those materials that increased dissolution time.What is the surgeon opinion regarding the (b)(4) blood in the abdomen? - it was assumed that the 1500 ml was a results of consistent seeping of blood from serosal layer of uterus secondary to suture failure.What does the surgeon believe caused/ contributed to the bleeding? - it was assumed that the 1500 ml was a results of consistent seeping of blood from serosal layer of uterus secondary to suture failure.What are the patient age, weight, and prior medical conditions? -age: (b)(4) -weight: (b)(4) -prior medical conditions: fibroids, seasonal allergies, varicella you provided 2 lots of suture, can you identify which lot was used on the patient? - both.What is the current condition of the patient? - she has been seen for one postoperative visit and is doing well.

• Brand Name: MCRYL+ UD 36IN 2-0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7642240
• Report Number: 2210968-2018-73884
• Device Sequence Number: 1861100
• Product Code: GAM
• UDI-Device Identifier: 10705031046795
• UDI-Public: 10705031046795
• Combination Product (Y/N): N
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: MCP945H
• Device Lot Number: LAZ145
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/01/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 06/27/2018
• Supplement Report FDA Received Date: 07/16/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SURGICEL, INTERCEDE
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 77