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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL

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ETHICON INC. PHYSIOMESH UNKNOWN PRODUCT MESH, SURGICAL Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Adhesion(s) (1695); Cyst(s) (1800); Erythema (1840); Seroma (2069)
Event Date 06/12/2020
Event Type  Injury  
Manufacturer Narrative
Product complaint #: (b)(4). Additional information was requested however not received. If further details are received at a later date a supplemental medwatch will be sent. Does the surgeon believe that ethicon products (dermabond, vicryl suture, nylon suture, physiomesh) involved caused and/or contributed to the post-operative complications described in the article? dermabond, vicryl suture, nylon suture: erythema. Physiomesh: seroma, large cyst, infected collection/abscess, adhesions. Does the surgeon believe there was any deficiency with the ethicon products (dermabond, vicryl suture, nylon suture, physiomesh) used in this procedure? was the case discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Note: events reported on mw# 2210968-2021-06081, mw# 2210968-2021-06082, mw# 2210968-2021-06083, mw# 2210968-2021-06084. This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided. Citation: citation: international journal of surgery case reports 72 (2020) 572¿576 ,https://doi. Org/10. 1016/j. Ijscr. 2020. 06. 034 , published by elsevier ltd on behalf of ijs publishing group ltd. This is an open access article under the cc by license (http://creativecommons. Org/licenses/by/4. 0/).
 
Event Description
It was reported in a journal article with title: management of a nine litre abdominal wall seroma post ventral hernia repairs: a case report. A (b)(6) year-old caucasian male presented with a large anterior abdominal wall collection on a background of a mesh repair of a recurrent incisional hernia with multiple previous abdominal operations. The mass measured 40 × 25 × 20 cm on abdominal computed tomography in january 2020. The patient¿s initial surgery was a paraumbilical hernia repair in 2002 followed by exploration of the repair later that year following concerns of infection. The patient underwent further operative intervention for bowel obstruction requiring resection in 2003 and repair of an incarcerated ventral hernia in 2010. The patient received a penultimate, massive, recurrent incisional hernia repair with onlay 20 × 30 cm ethicon physiomesh in 2013 at bmi 45. Subsequent to this he developed a vast collection requiring operative intervention in 2020. The small recurrence at superior end was repaired with 1-0 nylo (ethicon). An abdominoplasty was performed to remove redundant abdominal wall. Final closure was achieved with interrupted vicryl (ethicon) to dermisand staples to the skin. Two 19 french blakes drains (ethicon) were inserted. Reported complications included seroma large cyst or infected collection/abscess, adhesions. And mild erythema to the right side of the incision day three post-operative he remained on cefazolin and the erythema resolved. In conclusion this multimodal approach of drainage, capsulectomy and scarification was utilised for this patient with approximately twice the size and duration of seroma. He will be closely monitored and followed up for potential recurrence or subsequent infection.
 
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Brand NamePHYSIOMESH UNKNOWN PRODUCT
Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
ETHICON INC.
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
ETHICON INC.-GMBH
robert-koch strasse 1
p.o. box 1409
norderstedt D2284 1
GM D22841
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key12148022
MDR Text Key267744258
Report Number2210968-2021-06204
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K093932
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/09/2021 Patient Sequence Number: 1
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