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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Adhesion(s) (1695); Hematoma (1884); Pain (1994); Seroma (2069); Urinary Retention (2119); Hernia (2240); Post Operative Wound Infection (2446); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 10/16/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate. 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. Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details. Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics? (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. Events related to physiomesh captured via 2210968-2021-04737. Events related to securestrap captured via 2210968-2021-04738. Events related to pds ii captured via 2210968-2021-04739. Events related to ethibond suture captured via 2210968-2021-04740. Events related to prolene suture captured via 2210968-2021-04742. Citation cite: eur surg (2021) 53:60¿65, https://doi. Org/10. 1007/s10353-020-00671-y.
Event Description
Title: hybrid approach to ventral wall hernia repair: a single institution cohort study. The aim of this retrospective cohort study is to evaluate short- and long-term outcomes in patients undergoing hvr between october 2012 and june 2016. The surgical approach was standardised for all included patients. Fifty-six patients underwent hvr with surgery performed by four surgeons. Patients undergoing repair of ventral hybrid hernia utilized physiomesh (ethicon). The mean age was 48 years with a mean bmi of 32. 8kg/m2. 71. 4% had incisional hernias and 28. 6% had primary hernias. All hernia defects were identified laparoscopically, with adhesiolysis carried out in some cases. Thereafter, the hernia sac content was reduced into the abdominal cavity and the sac content was freed of adhesions. Upon reduction of all hernial contents into the abdominal cavity, pneumoperitoneum was reduced to 4mmhg to allow careful and accurate measurement of defect size. Subsequently, the open approach whereby an incision is made over the hernia defect, utilising the previous scar. The incision made is large enough to allow adequate dissection of the hernia sac and exposure of the fascial borders. The sac is then excised and hernia edges are cleared. Extracorporeal transfacial closure of the hernia defect was performed using either loop pds or interrupted ethibond (ethicon). This was then followed by a return to laparoscopy, where the closure was re-assessed. At that time, the mesh was appropriately sized and prepared for insertion with 2/0 prolene(ethicon) to allow the mesh to be lifted up with a parachute technique to ensure that the collagen side is against the abdominal cavity. The mesh was secured on the anterior abdominal wall using a double crown configuration technique with multiple 5-mm titanium spiral tacks (protack; covidien, ma) or securestrap (ethicon securestrap¿) placement along it borders every 2 to 3cm. Reported complications included adhesions,chronic pain (n
2) required postoperative intravenous patient-controlled analgesia, hernia recurrence(n
2), wound seroma (n
9), surgical site infection (n
2), urinary retention, ileus (n
1), respiratory complication (n
2), readmission(n
1) was due to postoperative haematoma at day 10. This was managed conservatively and the patient discharged within 1 day. In conclusion the hybrid technique is safe and feasible, and has important benefits including low rates of seroma formation, chronic pain and hernia recurrence. Future investigations may include randomized controlled trials to evaluate the benefits of vhr, with careful assessment of patient-reported outcome measures including quality of life and postoperative pain.
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Type of DeviceMESH, SURGICAL
Manufacturer (Section D)
1000 route 202
raritan NJ 08869
Manufacturer (Section G)
robert-koch strasse 1
norderstedt 22851
GM 22851
Manufacturer Contact
elba bello
1000 route 202
raritan, NJ 08869
MDR Report Key11841597
MDR Text Key251184839
Report Number2210968-2021-04737
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUK
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 05/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2021
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 Received05/11/2021
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
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 05/18/2021 Patient Sequence Number: 1