MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 1 S/A CTXB CR; SUTURES - ABSORBABLE

Catalog Number	PDPB765D
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Not Applicable (3189)
Date of Event	06/01/2020
Type of Reportable Event	Serious Injury
Additional 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 clarify 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, gender, weight, bmi at the time of index procedure? was the pds or pds plus suture used on fascia during initial procedure? did the patient receive any prophylactic antibiotics pre-, intra- or post-operation? please specify the patient¿s allergic history to medical device, food or medications? please provide a product lot number? other relevant patient history/concomitant medications? was there any allergy testing performed? if yes, results? did the operating surgeon observe any suture deficiency or anomaly before, during or after the suture placement? indication for debridement? what was the appearance of the suture during the debridement surgery? how much of suture was removed? was the re-suturing performed after debridement? are there any medical or surgical intervention planned for ¿reddening¿ (erythema) recurrence? please specify.What is physician¿s opinion as to the etiology of or contributing factors to these events (first time erythema with debridement and then erythema recurrence)? what is a current patient¿s status? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that the patient underwent a laparoscopically assisted distal gastrectomy on (b)(6) 2020, and the suture was used for closure of the small incision on the fascia.A month after the surgery, reddening occurred on the site where the suture had been used.Then, a debridement surgery was performed under general anesthesia.It was reported that sutures that could be removed were removed.A month after that, reddening occurred again.After the surgery, it became aware that the patient had some allergic tendencies.Recurrence of reddening is observed currently.There was no infection occurred.The surgeon opined that there was causal relationship between the symptom and the suture.Some allergic tendencies were observed such as ones against antibiotics.Additional information has been requested.
Additional Manufacturer Narrative
Date sent to the fda: 09/01/2020.Additional information was requested, and the following was obtained: please specify what suture was placed and then involved with reddening area: unknown pds suture or pdpb765d - pds plus suture, which was reported in the file initially?: so far, it is unknown if the affected suture was pds or pds plus.If it was pds plus, it was pdpb765d.Thus, (b)(6) reported to (b)(6) as the affected suture was pdpb765d.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Additional Manufacturer Narrative
Date sent to the fda: 08/17/2020.Additional information was requested, and the following was obtained: was the pds or pds plus suture used on fascia during initial procedure? - yes.Please clarify what sutures were used in another trocar wound with no reaction? - monodiox or pds.Please specify the patient¿s allergic history to medical device, food or medications? - some allergic tendencies were observed such as ones against antibiotics.What is physician¿s opinion as to the etiology of or contributing factors to these events (first time erythema with debridement and then erythema recurrence)? - during the first surgery, in another trocar wound, dermostitch was done with monodiox or pds without suturing the fascia.No reaction occurred at this site postoperatively.On the other hand, the reddening occurred on the small incision site where the fascia was sutured with pds plus or pds.Therefore, the surgeon assumed that there was causal relationship between the symptom and the pds or pds plus.What is a current patient¿s status? - recurrence of reddening is observed currently.Attempts are being made to clarify additional information received.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please clarify the response " yes" on the following question: was the pds or pds plus suture used on fascia during initial procedure? please specify what suture was placed and then involved with reddening area: unknown pds suture or pdpb765d -pds plus suture, which was reported in the file initially? this report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PDS PLUS VIO 8X18IN 1 S/A CTXB CR
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10374647
• Report Number: 2210968-2020-05916
• Device Sequence Number: 19474652
• Product Code: NEW
• UDI-Device Identifier: 10705031218901
• UDI-Public: 10705031218901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/27/2020

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 Catalogue Number: PDPB765D
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/27/2020
• Supplement Date Received by Manufacturer: 08/14/2020; 08/18/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 08/17/2020; 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention