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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFECELL CORPORATION STRATTICE SURGICAL MESH

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LIFECELL CORPORATION STRATTICE SURGICAL MESH Back to Search Results
Model Number 0608001
Device Problem Insufficient Information (3190)
Patient Problems Chest Pain (1776); Itching Sensation (1943); Nausea (1970); Rash (2033); Respiratory Distress (2045); Swelling (2091); Tachycardia (2095); Burning Sensation (2146); Urticaria (2278); Reaction (2414); Weight Changes (2607)
Event Date 01/05/2016
Event Type  Injury  
Manufacturer Narrative
Initial limited information was reported to lifecell on 02/18/2016. Follow up communication received on 03/31/2016 reported this patient's medical intervention. (b)(4) - qa investigation into lot sp100264 resulted in no remarkable findings with no similar complaints reported against the lot and no deviations or nonconformances revealed during processing. Lot sp100264 was terminally sterilized and met all qc release criteria. As of 04/01/2016, no similar complaints have been reported against lot sp100264. As of 04/01/2016, all 623 grafts released to finished goods for lot sp100264 have been distributed, including 183 grafts reported as implanted. (b)(4). Although the device remains implanted, comprehensive medical intervention was required to treat the patient's persistent symptoms. The patient's condition remains unresolved with intermittent hives and continues to take antihistamine, antiemetic and opioid pain medication. At this time, the surgeon cannot rule out the strattice as a contributing factor. Strattice is an acellular xenograft derived from porcine tissue that could elicit an immune response in patients with known sensitivity. The instructions for use notifies the customer that the porcine tissue grafts are contraindicated and should not be used in patients with a known sensitivity to porcine material or polysorbate 20, a component of the phosphate buffered aqueous solution. Although this patient has known allergies, it has not been confirmed if she is allergic to porcine material or polysorbate 20. No antibiotics are used in the processing of this product. Qa investigation into lot sp100264 resulted in no remarkable findings, including (b)(4) devices distributed with no similar complaints reported against the lot and no deviations or nonconformances revealed during processing. Lot sp100264 was terminally sterilized and met all qc release criteria. Remains implanted.
 
Event Description
Limited information was reported to lifecell on 02/18/2016 regarding a female patient claiming to have a possible allergic reaction following the implantation of strattice on (b)(6) 2015. Through follow up communication with the implanting surgeon, it was confirmed on (b)(6) 2016 that a female patient underwent a pre-peritoneal femoral hernia repair with the use of strattice on (b)(6) 2015. On (b)(6) 2016 (15 days post-op), the patient called her primary care physician complaining of sudden onset of hives, itching, swollen lips, nausea, tachycardia, hoarseness, and scratchy throat. She was then sent to the er and upon examination she was found to have diffuse urticaria over extremities, buttocks and abdomen and no mucus membrane involvement. She was treated with antihistamines and iv decadron. This patient's known allergies include atorvastatin, codeine, erythromycin, metronadazole, morphine, rosuvastatin, simvastatin, and adhesive tape. The following medical intervention was required to treat this patient's allergic reaction: on (b)(6) 2016, she returned to her primary care physician and was given an injection of solumedrol in the office. On (b)(6) 2016, the patient was admitted to the hospital for steroids and benadryl treatment and discharged home the next day. On (b)(6) 2016, she was re-admitted to the hospital with chest pain however no hives were present at this time. All tests were negative. On (b)(6) 2016, the patient was re-admitted to the hospital for constipation. On (b)(6) 2016 (approximately 1 month post-op), the patient contacted her primary care physician again complaining of itching, pruritis, scratchy throat and weight gain however no hives were present at this time. The patient believed that she still is having an allergic reaction to the mesh. The primary care physician recommended that the patient consult an allergist and the implanting surgeon, dr. (b)(6). On (b)(6) 2016, the patient went back to the er with prinzmetal's angina, urticarial rash to the abdomen where the mesh was implanted also to the right thigh, burning and itching. On (b)(6) 2016, the patient saw the primary care physician again with hives and shortness of breath. The primary care physician is not attributing the allergic response to the mesh. It was reported that the patient did not follow up with an allergist as recommended. On (b)(6) 2016 (approximately 2 months post-op), the patient saw the implanting surgeon dr. (b)(6) and upon examination was diagnosed with mild uritcaria along her ankles and was noted to have gained 13 pounds over a two month time period (from her pre-op visit). She was referred to a dermatologist for a patch test. The implanting surgeon is not attributing the allergic response to the strattice. On (b)(6) 2016 (approximately 3 months post-op), the patient was seen by the primary care physician again for unresolved hives, swelling and weight gain. Currently, the strattice remains implanted and the patient is continuing hydroxazine, zofran and oxycodone. She is no longer taking steroids but her condition remains unresolved with intermittent hives. At this point in time, the implanting surgeon dr. (b)(6) cannot rule out the strattice as the cause of this patient's allergic response.
 
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Brand NameSTRATTICE
Type of DeviceSURGICAL MESH
Manufacturer (Section D)
LIFECELL CORPORATION
one millennium way
branchburg NJ 08876
Manufacturer Contact
stanley dube
one millennium way
branchburg, NJ 08876
9089471575
MDR Report Key5606140
MDR Text Key43610120
Report Number1000306051-2016-00018
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070560
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 02/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/31/2017
Device Model Number0608001
Device Catalogue NumberN/A
Device Lot NumberSP100264
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2015
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: 04/25/2016 Patient Sequence Number: 1
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