MAUDE Adverse Event Report: ETHICON INC. PDSII CLR 18IN 4-0 S/A PS-3 PRM; SUTURE, SURGICAL, ABSORBABLE

Catalog Number W9873T

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 (b)(6) 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? note: events reported via mw 2210968-2019-89318.

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.

• Brand Name: PDSII CLR 18IN 4-0 S/A PS-3 PRM
• Type of Device: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: kara ditty-bovard ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 6107428552
• MDR Report Key: 9261572
• MDR Text Key: 169060905
• Report Number: 2210968-2019-89317
• Device Sequence Number: 1
• Product Code: NEW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: N18331
• 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
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W9873T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/04/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention