MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT; MESH, SURGICAL, POLYMERIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Local Reaction (2035); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/21/2013

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).(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: j clin surg, august 2013, vol.21, no.8.Doi: 10.3969/j.Issn.1005-6483.2013.08.030 if further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Event related to patient in case 2 reported via mw # 2210968-2021-02466, event related to patient in case 3 reported via mw # 2210968-2021-02467, event related to patient in case 4 reported via mw # 2210968-2021-02468, event related to patient in case 5 reported via mw # 2210968-2021-02469, event related to patient in case 6 reported via mw # 2210968-2021-02470, event related to patient in case 7 reported via mw # 2210968-2021-02471.

Event Description

It was reported in a journal article with title: analysis, prevention, and treatment of incision infection after inguinal hernia repair using ultrapro hernia system.Since 2008, ultrapro hernia system (uhs) has been used to repair inguinal hernia.By april 2013, 748 cases of inguinal hernia repair were completed, in which 7 cases of incision infection occurred.The 7 cases (all male, age ranged from 29 to 71 years, with an average of (55.3 ± 13.7) years ) of infection are analyzed retrospectively, in order to provide experience and basis for further prevention and treatment of incision infection after inguinal hernia surgery.The inguinal hernia repair of the preperitoneal space was carried out using uhs made by johnson & johnson of the united states.In case 1, the patient had postoperative (incision) infection at day 7.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed pathogenic bacteria of staphylococcus capitis subsp urealyticus.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.At follow up, the patient was cured.In case 2, the patient had postoperative (incision) infection at day 3 and other complication included scrotal effusion.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed pathogenic bacteria of staphylococcus capitis subsp urealyticus.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.In case 3, the patient had postoperative (incision) infection at day 7.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed pathogenic bacteria of staphylococcus epidermis.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.At follow up, the patient was cured.In case 4, the patient had postoperative (incision) infection at day 4 and other complication included scrotal effusion.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed pathogenic bacteria of staphylococcus epidermis.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.At follow up, the patient had a pain in the inguinal region.In case 5, the patient had postoperative (incision) infection at day 10.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed pathogenic bacteria of staphylococcus aureus.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.At follow up, the patient was cured in case 6, the patient had postoperative (incision) infection at day 8.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed no bacterial growth.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.At follow up, the patient was cured in case 7, the patient had postoperative (incision) infection at day 5.Bacterial culture of incision secretion and antibiotic sensitivity test were performed after incision redness, pain and exudation occurred which showed pseudomonas aeruginosa.The incision was opened partially, iodophor gauze strip and alcohol wet compress were used, and microwave physiotherapy was performed once a day.Antibiotics against gram-positive cocci were given for treatment and adjustment was made according to the treatment effect and drug sensitivity test.The incision had stage ii healing within 2 months, and no chronic sinus and worsened infection leading to removal of the patch occurred.At follow up, the patient was cured uhs is developed from another hernia system.The patch is lighter, the mesh filament is thinner, and the mesh size is large, which is conducive to the in-growth of one¿s own tissues and reduction of the incidence of infection.Nevertheless, standard operations are still an important factor for the prevention of postoperative incision infection.

• Brand Name: ULTRAPRO HERNIA SYSTEM UNKNOWN PRODUCT
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082182213
• MDR Report Key: 11512285
• MDR Text Key: 240578679
• Report Number: 2210968-2021-02465
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention