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Catalog Number UNKAA052
Device Problems Defective Device (2588); Folded (2630); Detachment of Device or Device Component (2907)
Patient Problems Adhesion(s) (1695); Nerve Damage (1979); Swelling (2091)
Event Date 03/18/2015
Event Type  Injury  
Manufacturer Narrative
Currently, it is unknown to what extent the device may have caused or contributed to the reported event. To date no medical records have been provided. Without a lot number a review of the manufacturing records could not be conducted. The patient's legal claim alleges the patient experienced pain, rash, ab pain, swelling, recurrence, nerve damage, scar tissue, adhesions, folded mesh and detachment of mesh. While recurrence is alleged in the legal claim, based off the information provided it appears that the patient experienced a second hernia in the same area and not an actual recurrence of the original hernia that was repaired on (b)(6) 2015. While there does not seem to be a recurrence of the original hernia, recurrence and adhesions are both listed as possible adverse reactions in the instructions-for-use. With the currently available information, and due to the patient's extensive medical/surgical history which is significant for implant of more than one mesh and additional interventions, it is unclear at this time to what extent the unspecified bard perfix light plug mesh may have may have contributed to the problems experienced by the patient. With the current information, no definitive conclusion can be made. If additional event and/or evaluation information is obtained, a follow up mdr will be submitted. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. Not returned to manufacturer.
Event Description
The following was reported to davol by the patients' attorney: on (b)(6) 2015 - patient underwent an open repair with implant of a bard perfix light plug mesh with four sutures, one in each corner. On (b)(6) 2015 - patient woke in excruciating pain in his groin and was brought to the er. The hospital prescribed the patient with pain medication and sent him home. The hospital staff told the patient that since they did not perform the surgery on him, they were not able to perform any procedures on him. The patient's mother called his doctor and was told by the surgeon that the pain was normal for that type of procedure. On (b)(6) 2015 - patient noted his right testicle was very swollen. Patient went to the er where they performed an ultrasound, results indicated an accumulation of fluid in his right groin/testicle. Patient was referred to a urologist. Later in the week the patient spoke with his surgeon who assured him that the fluid build up was normal. On (b)(6) 2015 - patient presented for an mri which the radiologist had changed to a cat scan (without the surgeons permission) because the radiologist believed the patient was implanted with "metal mesh" and was concerned the mri would not see the "metal mesh. " however, the mesh implanted was made of polypropylene, which will decompose faster when in contact with gamma rays, which a cat scan emits. After the cat scan the patient began to feel very ill. A rash began to spread to the patient's stomach, which moved to his chest, neck and face where it remains. On (b)(6) 2015 - cat scan results revealed there was mass in the groin area. Another mri was reordered. On (b)(6) 2015 - patient had an mri performed to see where the mesh was. On (b)(6) 2015 - mri results showed that a mass was folded on itself and the radiologist identified it as mesh. On (b)(6) 2015 - patient had a sneezing fit, which resulted in his hernia rupturing again. The mesh was allegedly no longer connected to his muscle. On (b)(6) 2015 - patient had a consult with another surgeon for a second opinion who confirmed the patient had a second hernia in the same area. On (b)(6) 2015 - patient underwent a second hernia repair surgery. The patient had a robotic assisted laparoscopic hernia repair with implant of a (non bard/davol) prolene mesh. This was placed underneath the muscle cavity to repair the hernia which was placed underneath the perfix plug. Postoperatively the patient felt a sharp, excruciating pain in his lower right abd. The patient's original perfix plug mesh was not removed to determine if the rash would go away on its own through time. Post procedure the patient¿s rash had not resolved. On (b)(6) 2015 - patient underwent partial removal of the bard perfix plug. During the procedure, the surgeon allegedly found "that the original mesh had been tangled with the nerves and 2% of the mesh concreted onto the patient¿s spermatic cord which he was unable to remove. " on (b)(6) 2015 - patient had a follow up md visit to have his catheter removed. During this time, the surgeon noted that the patient's rash had disappeared "which indicated that the patient had been allergic to the original mesh. " on (b)(6) 2015 - patient had a follow up md visit. The surgeon recommended pain management to deaden the nerves in the groin, an allergist to test for an allergy to the mesh, and ordered an ultrasound for the groin/testicle area to test the blood flow to the right testicle. On (b)(6) 2015 - a second ultrasound was performed, results allegedly indicated that the mesh had caused the patient's spermatic cord torsion. On (b)(6) 2016 - patient allegedly felt a shift in the mesh, which caused a lot of discomfort in his groin and testicle. On (b)(6) 2016 - patient presented to the hospital er due to complaints of light headedness. When he arrived to the hospital they indicated he had an elevated temp due to fighting an infection. Patient was sent home that same day after the hospital determined that they couldn't figure out what was wrong with him. On (b)(6) 2016 - patient presented to the hospital er as he started to lose his equilibrium and fell. Patient lost consciousness in the er. He had numerous diagnostic tests performed which could not identify the source of the problem. Patient¿s blood work indicated that his liver was being attacked. Patient began to lose control in his legs. On (b)(6) 2016 - the patient was released from the hospital without any surgical intervention being performed. Patient allegedly could still not move his legs at this time. Patient was rushed to another facility where an mri of the lower spine was performed. The doctors found some swelling in the lower spinal cord and prescribed some muscle relaxers and steroids. Within a month, the patient was able to ambulate with use of a cane. Patient remained in pain because of his groin and right testicle. On (b)(6) 2016 - patient underwent removal of both meshes. It was found that allegedly 40% of the original mesh (davol) was tangled around the spermatic cord. The surgeon did his best to remove the mesh tangled around the cord. Of note the (non-bard davol) prolene mesh was noted to be tangled around a lot of nerves and tissue near the groin and lower right belly area, this was also removed. Postoperatively the patient awoke in excruciating pain and swelling in his right testicle. An ultrasound of the patient's right testicle found that the testicle had "died. " patient returned to the or for emergent surgery and had his right testicle removed. Allegedly two days after this procedure the patient found that the rash that previously was all over his face had gone away. On (b)(6) 2016 - the patient underwent a nerve block procedure. After the procedure was done, once the numbing medication wore off near his belly the pain had increased because it was creating more pressure in his belly and groin areas. On (b)(6) 2016 - patient underwent multiple physical therapy sessions. The patient¿s physical therapist noted ¿she had never seen more scar tissue and she also noted, ¿a major nerve stuck in scar tissue in his lower abd which was creating a significant amount of pain. On (b)(6) 2016 - patient had multiple pain medications prescribed, multiple doctor office visits and diagnostic tests performed that showed the patient¿s liver since the removal of the mesh had started to heal, however, blood work indicated there was a problem with his liver. On (b)(6) 2016 - patient had a follow up visit with a dermatologist. It was noted that the patient's rash had not gone away, so they believe that part of the defective mesh was left in his body.
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Manufacturer (Section D)
100 crossings blvd.
warwick RI 02886
Manufacturer (Section G)
san geronimo industrial park
lot #1, road #3, km 79.7
humacao PR 00791
Manufacturer Contact
steven figueroa
100 crossings blvd.
warwick, RI 02886
MDR Report Key6493028
MDR Text Key72790128
Report Number1213643-2017-00242
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Attorney
Type of Report Initial
Report Date 04/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKAA052
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2017
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? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/14/2017 Patient Sequence Number: 1