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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Hematoma (1884); Unspecified Infection (1930); Nausea (1970); Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 04/04/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4). ¿ 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. ¿ the single complaint was reported with multiple events. There are no additional details regarding the additional events. ¿ citation: irish journal of medical science (1971 -) (2019) 188:13571362 https://doi. Org/10. 1007/s11845-019-02012-9 ¿ 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. ¿ were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Does the surgeon believe that the ethicon product (physiomesh) involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with the ethicon product involved? patient demographics? if information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event Description
It was reported in a journal article with title: laparoscopic ventral hernia repair with intraperitoneal onlay meshresults from a general surgical unit. This study aimed to review our experience with ipom in the repair of ventral hernia by a single surgical team. A total of 108 patients undergoing laparoscopic ipom for ventral hernia in a single surgical service from 01/01/2010 to 01/12/2016 were included. Following confirmation of peritoneal access, adhesiolysis was performed when required utilising a combination of sharp and blunt dissection. The necessity for adhesiolysis was variable as several procedures were performed for recurrent incisional hernias or for herniation following major abdominal surgery. Use of diathermy and ultrasonic scalpel was limited to minimise risk of iatrogenic intestinal injury. If required, the falciform ligament was taken down to facilitate adequate space for mesh placement in abdominal wall defect. The herniation was reduced in its entirety. Primary closure of the fascial defect was then performed with intra-abdominal suturing using nonabsorbable monofilament suture. The predominant suture material was endoknot¿ suture (ethicon), although nonabsorbable locking suture (v-lock by medtronic) was utilised in later cases. Adjuvant component separation was not performed. The mesh was placed intraperitoneally via the 10-mm camera port. Meshes included composite physiomesh" (ethicon, subsequently withdrawn) or parietex" (medtronic). A minimum overlap of 5 cm outside the sutured fascial defect was utilised to allow for mesh shrinkage. The mesh was secured with absorbable tacks in a double crown pattern (absorbatack" medtronic). Patients were discharged on the day of surgery. Eightyseven patients (80. 5%) had repair using parietex"composite, a hydrocolloid-treated lightweight polyester mesh (medtronic. ) the remainder were repaired with physiomesh", a composite polypropylene (ethicon). The mean operating time was 82. 98 ¿ 33. 5 min. Seventy-four (68. 5%) of the patients were admitted on the day of surgery and stayed an average of 2. 9 days (median 1 day with a range from 1 to 55 days). Patients were initially reviewed in the surgical outpatients department post-operatively with long-term follow-up achieved utilising a postal questionnaire. Nonresponders were surveyed by telephone. Any patient reporting difficulty was again recalled to the surgical outpatient department for re-examination. Reported complications included n
7 mild desaturation, n
8 acute post-operaitve pain, n
1 wound hematoma, n
3 nausea, n
2 ileus, n
3 urinary retention, n
1 post-operative infection, n
1 undetected enterotomy, n
1 seroma, n
1 enterocutaneous fistula and n
2 hernia recurrence. In conclusion, our experience in lvhr with ipom has shown that it can be safely and effectively used in a variety of hernia morphology and is suitable for large and recurrent hernias. Complication and recurrence rate was lower than open repair and comparable to other laparoscopic techniques for mesh repair. There is a need for longterm observational studies to assess for mesh complications well beyond a typical 5-year follow-up as mesh implantation is a life-long prosthetic device.
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Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
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 Key12148165
MDR Text Key267746981
Report Number2210968-2021-06205
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeEI
PMA/PMN Number
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 Received07/10/2021
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: 07/10/2021 Patient Sequence Number: 1