MAUDE Adverse Event Report: ETHICON INC. ETHILON BLK10-0 20 CS-B-6(2); NYLON SUTURE, MONOFILAMENT

Model Number 9008G

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Inflammation (1932)

Event Date 07/12/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.The international affiliate reports the following possible batch number: kkr487.Mfg.Date: 09/13/1997, exp.Date: 12/31/2003.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.

Event Description

It was reported that a patient underwent a c-section procedure on (b)(6) 2019 and suture was used.It was reported that on (b)(6) 2019, the patient's incision got red and she suffered inflammation.Spectrum was given to the incision, and then bactroban and mirabilite were used on the patient to strengthen anti-inflammatory treatment.The patient condition then changed better.The physician opines that the contributing factors to this event was the poor healing of the abdominal incision.Additional information has been requested.

Manufacturer Narrative

(b)(4).Additional information was requested and the following was obtained: please confirm: is the product code involved is 9008g? unk, this case is from health authority, the information reported by hospital is lot number kkr487, no product code provided.The manufacturing records for lot kkr487 indicate that the expiration date is 12/31/2003 and manuf date is 9/13/1997.Please confirm: is the lot number involved kkr487? unk, this case is from health authority, the information reported by hospital is lot number kkr487.

• Brand Name: ETHILON BLK10-0 20 CS-B-6(2)
• Type of Device: NYLON SUTURE, MONOFILAMENT
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8950294
• MDR Text Key: 156492603
• Report Number: 2210968-2019-86435
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 9008G
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 23 YR