MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 27IN 3-0 S/A FS-1; SUTURE, SURGICAL, ABSORBABLE

Model Number Z442H

Device Problem Break (1069)

Patient Problems Local Reaction (2035); Not Applicable (3189)

Event Date 10/03/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).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, weight, bmi at the time of index procedure the diagnosis and indication for the index surgical procedure? in what tissue layer was the suture used? what was the tissue condition pre-op, i.E., normal or thin, calcified, fragile, diseased? what was the tissue condition post-op, i.E., normal or thin, calcified, fragile, diseased? what were the current symptoms following the index surgical procedure? onset date? please clarify and describe what is meant by ¿two ears peel off¿? was medical intervention provided for the report of ¿two ears peel off¿? if yes, please describe.What was the appearance of the suture during reoperation on october 3, 2019? are patient photos available? other relevant patient history/concomitant medications product code and lot # if applicable, will the product be returned, return date, tracking information what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient¿s current status? events reported via mw 2210968-2019-89317.

Event Description

It was reported that the patient underwent otoplasty on (b)(6) 2019 and suture was used for plication and attachment of concha.In (b)(6) 2019, two ears got peeled off.The patient was operated again on (b)(6) 2019 and no suture was found except a 3.0 absorbable suture on the right concha.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Date sent to the fda: 02/13/2020.Additional information: d10, h6.Additional h3 device evaluation summary: three suture pieces of product code z442h was received for analysis.During the visual inspection of the used suture pieces, body fluids and tissue were noted.The product code z442h is absorbable suture and at the time of the second surgery, the suture was on 103 days of the implantation at this time the suture was found absorbed according to the percentage of the original strength, the pds ii clear device is completely absorbed by 182 days post implantation.The manufacturing records could not be reviewed as the batch number is unknown.According to the sample condition, the cause could not be determined.

• Brand Name: PDSII CLR 27IN 3-0 S/A FS-1
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9261574
• MDR Text Key: 169023394
• Report Number: 2210968-2019-89318
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10705031060975
• UDI-Public: 10705031060975
• Combination Product (y/n): N
• PMA/PMN Number: N18331
• 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: 10/04/2019

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
• Device Operator: Health Professional
• Device Model Number: Z442H
• Device Catalogue Number: Z442H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2020
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 02/10/2020
• Supplement Dates FDA Received: 02/13/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention