MAUDE Adverse Event Report: ETHICON INC. PVP MEDIUM 6.4CM X 6.4CM; MESH, SURGICAL, POLYMERIC

Catalog Number PVPM

Device Problem Material Fragmentation (1261)

Patient Problems Foreign Body Reaction (1868); Not Applicable (3189)

Event Date 07/11/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.The patient demographic info: age, weight, bmi at the time of index procedure date and name of initial surgical procedure: the diagnosis and indication for the initial surgical procedure? can you provide more details on reaction that occurred? are photos of reaction available? how long after initial procedure was reaction noted? describe any medical/surgical intervention including reason, dates and surgical findings.Other relevant patient history/concomitant medications: what is physician¿s opinion as to the etiology of or contributing factors to this event what is the patient's current status?.

Event Description

It was reported that the patient underwent an unknown surgical procedure on unknown date and the mesh was implanted.Two weeks later, the patient experienced unclear reactions after surgery and the mesh was explanted.The surgeon found that the ring of implant had broken into many small pieces.It was also reported that the patient currently is well.Additional information has been requested.

Manufacturer Narrative

Pc-(b)(4).Date sent to the fda: (b)(4) 2018.A used proceed ventral patch of product code (b)(4) was returned for analysis.During the visual inspection of sample, body fluids and a tissue of 1.75¿ of length was noted on the ventral patch.The ventral patch has begun with degradation process; since, there are fragments of the pds base plate on the sample and the tissue.Per the condition of sample received, it could not be determined what may have caused the reported incident.

Manufacturer Narrative

Date sent to the fda: (b)(4) 2018.Additional information:- the actual device batch number associated with this event is not known.As per health authority request, the international affiliate reports the following possible distributed batch numbers : (b)(4) batch# (b)(4).Mfg.Date: (b)(4) 2017; exp.Date: (b)(4)/2019 batch# (b)(4) mfg.Date: (b)(4) 2018; exp.Date: 1(b)(4) 2019 in addition, a review of the batch manufacturing records for the possible batch numbers was conducted and the batches met all finished goods release criteria.

• Brand Name: PVP MEDIUM 6.4CM X 6.4CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7722872
• MDR Text Key: 115121394
• Report Number: 2210968-2018-74639
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132405
• UDI-Public: 10705031132405
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PVPM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR