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U.S. Department of Health and Human Services

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

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ETHICON PROLENE HERNIA SYSTEM PROLENE MESH HERNIA SYSTEM Back to Search Results
Catalog Number PHSL6
Device Problem Other (for use when an appropriate device code cannot be identified)
Event Type  Injury  
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.

 
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.

 
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). 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).

 
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Brand NamePROLENE HERNIA SYSTEM
Type of DevicePROLENE 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 Key2119043
Report Number2210968-2011-00743
Device Sequence Number1
Product CodeFTL
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 Received06/09/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/31/2015
Device Catalogue NumberPHSL6
Device LOT Number22499-08
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Device Age6 mo
Event Location Other
Date Manufacturer Received09/05/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/01/2010
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
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