MAUDE Adverse Event Report: ETHICON PROLENE HERNIA SYSTEM PROLENE MESH HERNIA SYSTEM

Catalog Number PHSL6

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problems Unspecified Infection (1930); Pain (1994); Strangulation (2084); Surgical procedure (2357); Treatment with medication(s) (2571)

Event Type  Injury  

Event Description

It was reported by the patient that he underwent a left inguinal hernia repair on (b)(6) 2011 and mesh was used. Within a month of the procedure, the patient experienced a lot of pain and infection. He also stated that he felt something didn't belong there. The patient contacted his physician who prescribed antibiotics for the infection. The patient had a second opinion as well. There is no additional information.

Manufacturer Narrative

(b)(4). Infection. Conclusion: no conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.

Manufacturer Narrative

(b)(4). Corrected information: narrative - it was reported by the patient that he underwent a left inguinal hernia repair on (b)(6) 2011 and mesh was used. Within a month of the procedure, the patient experienced pain. Several months after the surgery it was noted that there was a hole in the incision and the patient had an infection. The patient contacted his physician who prescribed antibiotics for the infection. During 2012 the patient had a second procedure to remove the mesh. The patient reports the mesh had become wrapped around blood vessels and nerves. He required a partial vasectomy to restore blood flow to his left testicle. No further information is available. In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria. This medwatch report is in response to receipt of maude event report mw (b)(4).

Manufacturer Narrative

It was reported that the patient underwent a left inguinal hernia repair and mesh was implanted on (b)(6) 2011. It was reported that post operatively he experienced pain, redness, oozing and infection at the site of the surgery. He was rx antibiotics in (b)(6) 2011 for the ¿open wound. ¿ on (b)(6) 2012, he underwent surgery to remove the mesh, and it was found that the mesh was deteriorated, wrapped around nerves, which required a neurectomy and partial vasectomy to restore blood flow to his left testicle. He continues to experience burning pain in abdomen, genitals, thigh and hip and unable to engage in sexual relations.

• Brand Name: PROLENE HERNIA SYSTEM
• Type of Device: PROLENE MESH HERNIA SYSTEM
• Manufacturer (Section D): ETHICON; route 22 west; po box 151; somerville NJ 08876
• Manufacturer (Section G): J-PAC; 25 centre road; somersworth NH 03878
• Manufacturer Contact: daniel lamont ; route 22 west; po box 151; somerville, NJ 08876 ; 9082182708
• MDR Report Key: 2119043
• MDR Text Key: 2021061
• Report Number: 2210968-2011-00743
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: PATIENT
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 06/09/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 07/31/2015
• Device Catalogue Number: PHSL6
• Device LOT Number: 22499-08
• Was Device Available For Evaluation?: No
• Is The Reporter A Health Professional?: No
• Device Age: 6 mo
• Event Location: Other
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 07/01/2010
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 06/09/2011 Patient Sequence Number: 1