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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN
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GENZYME CORPORATION(FRAMINGHAM) SEPRAFILM; MCN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fever (1858); Unspecified Infection (1930); Inflammation (1932); Pain (1994)
Event Date 02/15/2019
Event Type  Injury  
Event Description
Pelvic dead space inflammation [pelvic infection] ([pelvic pain], [pyrexia]).Case narrative: initial information received on 10-apr-2019 regarding an unsolicited valid serious case received from a physician.This case involves a 41 years old female patient (157 cm and 86.6 kg) who experienced pelvic dead space inflammation, while she was treated with the use of medical device carboxymethylcellulose, sodium hyaluronate [seprafilm].The patient's past medical history included hypertension, caesarean section and caesarean section.The patient's past medical treatment(s), vaccination(s) and family history were not provided.At the time of the event, the patient had ongoing obesity and uterine cancer and was a tobacco user.Underlying disease: corpus uteri carcinoma (severity before the administration of seprafilm: mild).The patient's constitution (such as allergy): none.History of adverse drug reaction: none.Drinking: none.Smoking: presence: 10 cigarettes/day.History of surgery: caesarean section twice (at the age of 29 years and 32 years).Notes: inpatient.Concomitant medications included flurbiprofen axetil (ropion) for analgesic therapy; pentazocine hydrochloride (sosegon [pentazocine hydrochloride]) for analgesic therapy; hydroxyzine embonate (atarax-p [hydroxyzine embonate]) for sedation; metoclopramide (metoclopramide) for vomiting; ranitidine hydrochloride (zantac) for vomiting; cefmetazole sodium (cefmetazole na) for infection prophylaxis; heparin calcium (heparin ca) for thrombosis prophylaxis; and enoxaparin sodium (clexane) for thrombosis prophylaxis.On (b)(6) 2019, operative method: laparoscopic abdominal surgery for uterine malignancy general anesthesia.Number of the used seprafilm: one.Application site: pelvic floor.In (b)(6) 2019, finding of pain in the left pelvic floor only was observed.On 15-feb-2019, at 19:00, pyrexia of 39 degrees centigrade occurred.The samples for two sets of blood culture, urine culture, and vaginal discharge culture were taken.Pelvic dead space inflammation developed (treatment: meropenem was started) site of appearance: the positional relationship to the application site was unknown.Thereafter, no pyrexia of above 37 degrees centigrade occurred.In (b)(6) 2019, the pyrexia of 39 degrees centigrade resolved.In (b)(6) 2019, the pain in the left pelvic floor resolved.On (b)(6) 2019, the pelvic dead space inflammation resolved.On an unknown date, the re-administration of seprafilm was not performed.The patient developed an event of a serious pelvic dead space inflammation (pelvic infection).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious pyrexia of 39 degrees centigrade (pyrexia).This event was assessed as medically significant.The patient was hospitalized for this event.The patient developed an event of a serious pain in the left pelvic floor (pelvic pain).This event was assessed as medically significant.The patient was hospitalized for this event.Relevant laboratory test results included: alanine aminotransferase - on (b)(6) 2019: 15 iu/l; on 15-feb-2019: 20 iu/l; on (b)(6) 2019: 20 iu/l.Aspartate aminotransferase - on (b)(6) 2019: 18 iu/l; on 15-feb-2019: 22 iu/l; on (b)(6) 2019: 18 iu/l.Blood albumin - on (b)(6) 2019: 3.8 g/dl; on 15-feb-2019: 2.9 g/dl; on (b)(6) 2019: 2.8 g/dl.Blood bilirubin - on (b)(6) 2019: 0.62 mg/dl; on 15-feb-2019: 0.74 mg/dl; on (b)(6) 2019: 0.60 mg/dl.Blood chloride - on (b)(6) 2019: 105 meq/l; on 15-feb-2019: 101 meq/l; on (b)(6) 2019: 105 meq/l.Blood creatinine - on (b)(6) 2019: 0.54 mg/dl; on 15-feb-2019: 0.66 mg/dl; on (b)(6) 2019: 0.58 mg/dl.Blood lactate dehydrogenase - on (b)(6) 2019: 151 iu/l; on 15-feb-2019: 144 iu/l; on (b)(6) 2019: 116 iu/l.Blood potassium - on (b)(6) 2019: 4.1 meq/l; on 15-feb-2019: 3.7 meq/l; on (b)(6) 2019: 4.6 meq/l.Blood sodium - on (b)(6) 2019: 139 meq/l; on 15-feb-2019: 135 meq/l; on (b)(6) 2019: 142 meq/l.Blood test - on (b)(6) 2019: 10.9 unk [10.9 sec].Blood urea - on (b)(6) 2019: 11.4 mg/dl; on 15-feb-2019: 8.8 mg/dl; on (b)(6) 2019: 10.1 mg/dl.Body temperature - on 15-feb-2019: 39 cel.C-reactive protein - on (b)(6) 2019: 0.40 unk [0.40]; on 15-feb-2019: 15.33 unk [15.33]; on (b)(6) 2019: 2.36 unk [2.36].Haematocrit - on (b)(6) 2019: 38.3 %; on 15-feb-2019: 36.7 %; on (b)(6) 2019: 35.2 %.Haemoglobin - on (b)(6) 2019: 12.2 g/dl; on 15-feb-2019: 11.7 g/dl; on (b)(6) 2019: 11.1 g/dl.Platelet count - on (b)(6) 2019: 280 10*4/ul; on 15-feb-2019: 252 10*4/ul; on (b)(6) 2019: 306 10*4/ul.Protein total - on (b)(6) 2019: 7.2 g/dl; on 15-feb-2019: 7.1 g/dl; on (b)(6) 2019: 6.3 g/dl.Red blood cell count - on (b)(6) 2019: 4.80 10*4/ul; on 15-feb-2019: 4.60 10*4/ul; on (b)(6) 2019: 4.33 10*4/ul.White blood cell count - on (b)(6) 2019: 9900 /ul; on 15-feb-2019: 17100 /ul; on (b)(6) 2019: 9600 /ul.Final diagnosis was pelvic dead space inflammation.The patient was treated with meropenem (meropenem).The patient outcome is reported as recovered / resolved on (b)(6) 2019 for pelvic dead space inflammation, as recovered / resolved in (b)(6) 2019 for pyrexia of 39 degrees centigrade and as recovered / resolved in (b)(6) 2019 for pain in the left pelvic floor.Reporter comment: causal relationship of the pelvic dead space inflammation to seprafilm: highly probable.Other possible factors for the pelvic dead space inflammation: the patient's risk factor: obesity.The patient had obesity as background, and there was a possibility of intra-abdominal infection due to the application of seprafilm induced by intracelial infection.The examination showed pain in the left pelvic floor only, which was consistent with the possibility.Additional information was received on 23-may-2019: investigation summary (#(b)(4), event id: (b)(4)) was received (added company comment).
 
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Brand Name
SEPRAFILM
Type of Device
MCN
Manufacturer (Section D)
GENZYME CORPORATION(FRAMINGHAM)
76 new york avenue
framingham 01701
Manufacturer (Section G)
GENZYME CORPORATION(FRAMINGHAM)
76 new york avenue
framingham 01701
Manufacturer Contact
heather schiappacasse
55 corporate drive, ms 55b-220
a
bridgewater 08807
MDR Report Key8903583
MDR Text Key155854103
Report Number1220423-2019-00010
Device Sequence Number1
Product Code MCN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/16/2019
Is the Device Single Use? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Weight87
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