MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO 15 X 30 CM, 1 / BOX; MESH, SURGICAL, POLYMERIC

Catalog Number UMT1

Device Problem Material Rupture (1546)

Patient Problems Hernia (2240); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.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 obtain the additional information.To date no response has been provided.If further details are received at the later date a supplemental medwatch will be sent.Was the hernia repair on (b)(6) 2017 associated with this event performed on primary or recurrent hernia? what was the defect size/type/location of the hernia associated with this event? mesh size and overlap? was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? if applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e.G.Graspers crimping the mesh fibers how much time from initial hernia repair on (b)(6) 2017 to hernia recurrence? was there any triggering event prior to present recurrence? (e.G.Weight gain, sneezing, coughing, strenuous activity)? how was the recurrence diagnosed? "if reoperation, surgical findings: please provide the date of reoperation mesh location and integrity was any deficiency or anomaly of the mesh? if yes, please describe it.Are there any pictures available?".

Event Description

It was reported that the patient underwent a hernia repair on (b)(6) 2017 and the mesh was implanted.Then the patient underwent a treatment of re-appearance of incisional hernia and the rupture in the center of mesh was discovered.Hernial opening was closed with other device.Additional information has been requested.

Manufacturer Narrative

Date sent to the fda: (b)(4) 2018.Prolene suture.Device code: (b)(4).Additional information was requested and the following was obtained : 1.Was the hernia repair on (b)(4) 2017 associated with this event performed on primary or recurrent hernia? event is referring to recurrent surgical treatment of hernia after direct closure of epgastric incisional hernia 10/16.2.What was the defect size/type/location of the hernia associated with this event? incisional hernia (ehs m2, w1); median epigastrical, hernial opening 11x3 cm 3.Mesh size and overlap? ultrapro mesh 15x30 cm, cranial overlap several cm; caudally nearly complete incision was lined.4.Was the procedure associated with this event open or laparoscopic? if applicable in what tissue layer did you place the mesh? (onlay, retro-muscular, extra peritoneal or intra abdominal) if applicable, closure of the defect (yes or no), use of stay sutures (how many), permanent or absorbable? - conventional, open treatment, sublay technique, mesh placed retropectorally on back part of rectus sheath.Back part of rectus sheath was closed with continous vicryl suture size 1, abdominal fascia was closed with monocryl.5.If applicable, the mesh fixation technique: device and technique? (single or double crown; spacing between implants) were there any surgical instruments used in the placement of the mesh that might have damaged the mesh? e.G.Graspers crimping the mesh fibers mesh was fixed on back part of rectus sheath with prolene interrupted suturing, size 2.No instruments were used, that could have damaged the mesh.6.Was there any triggering event prior to present recurrence? (e.G.Weight gain, sneezing, coughing, strenuous activity)? no triggering events known.7.How was the recurrence diagnosed? patient came in with new protrusion directly above navel.Ct of abdomen was performed.8."if reoperation, surgical findings: please provide the date of reoperation? june 27.2018; 9.Mesh location and integrity? mesh was found in correct layer.Mesh showed rupture (3 cm).Other parts of mesh were intact.Left side: approx.3 cm mesh, right side: 4,4 cm.Mesh originally was 15 cm.Mesh shrinking nearly 50 %.10.Was any deficiency or anomaly of the mesh? if yes, please describe it.See above 11.Are there any pictures available?" yes.

Manufacturer Narrative

Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Device evaluation summary: an used ultrapro piece of product code umt1 was returned for analysis.During the visual inspection of sample, the ultrapro piece was coated with a layer of body fluids that not let analyzed the sample.In addition, prolene, vicryl and green ethibond suture pieces tied to the sample could be observed.The suture pieces were examined and the prolene suture present damaged (dent) and the end of all sutures were noted cut that appears to be by the use of a surgical instrument.Per the condition of sample received, it could not be determined what may have caused the reported event.

• Brand Name: ULTRAPRO 15 X 30 CM, 1 / BOX
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; norderstedt ; GM
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7730000
• MDR Text Key: 115351019
• Report Number: 2210968-2018-74704
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K033337
• 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,Followup,Followup
• Report Date: 07/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Catalogue Number: UMT1
• Device Lot Number: KH8DKPX0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/31/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention