MAUDE Adverse Event Report: GENZYME BIOSURGERY (RIDGEFIELD) SYNVISC ONE; MOZ

Lot Number 8RSL028

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aspiration/Inhalation (1725); Arthralgia (2355); Joint Swelling (2356); No Code Available (3191)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Peritonitis [peritonitis] ; problems between skin and organs with burning sensation/ as if it were a herniation [burning sensation] ; impaired healing [impaired healing] ; recurrent abdominal distension/swollen stomach [abdominal distension] ; recurrent constipation [constipation] ; vomiting [vomiting] ; recurrent abdominal pain [abdominal pain] ; fever [fever] ; allergic reaction [allergic reaction].Case narrative: upon internal review on 05-dec-2018, this case initially considered as non-serious was updated to serious as the medically significant event of peritonitis was added.This case is related to case id: (b)(6) (duplicate).Initial information received on (b)(6) 2018 regarding an unsolicited valid non-serious case received from a patient from united states.This case involves an adult female patient who was treated with carboxymethylcellulose, sodium hyaluronate (seprafilm) and after unknown latency experienced problems between skin and organs with burning sensation/ as if it were a herniation, impaired healing, recurrent abdominal distension/swollen stomach, peritonitis, allergic reaction, recurrent constipation, vomiting, recurrent abdominal pain and fever.The patient's past medical treatment(s), history, vaccination(s) and family history were not provided.On an unknown date in 2016, the patient was implanted with carboxymethylcellulose, sodium hyaluronate sheet after bowel obstruction surgery in context of an intestinal occlusion.On an unknown date in 2016, after the surgery, patient reported problems between skin and organs with burning sensation, impaired healing, vomiting and fever since seprafilm insertion.On an unknown date, after unknown latency, patient also presented with recurrent episodes of adverse events, in particular after some meals: abdominal distention/swollen stomach, allergic reaction, peritonitis, abdominal pain, constipation and no diarrhea.On (b)(6) 2018, she would have an appointment with a surgeon about these disorders.Final diagnosis was fever, recurrent abdominal pain, vomiting, recurrent constipation, recurrent abdominal distention/swollen stomach, allergic reaction, peritonitis, impaired healing and problems between skin and organs with burning sensation/ as if it were a herniation.It was not reported if the patient received a corrective treatment.The patient outcome is reported as not recovered / not resolved on an unknown date for problems between skin and organs with burning sensation/ as if it were a herniation, impaired healing, vomiting, fever, abdominal distension/swollen stomach, allergic reaction, peritonitis and unknown for abdominal pain and constipation.Seriousness criteria: medically significant for peritonitis a product technical complaint was initiated with results pending for the same.Upon internal review on 05-dec-2018, this case was identified as duplicate of case id: (b)(6) and all the information from case id (b)(6) was merged into this case.The case was upgraded to serious.Additional events of allergic reaction and peritonitis were added along with details.The event term abdominal distension was updated to abdominal distension/swollen stomach and outcome was updated from unknown to not recovered.Indication of seprafilm was added.Related case was added.Clinical course was updated and text was amended accordingly.

• Brand Name: SYNVISC ONE
• Type of Device: MOZ
• Manufacturer (Section D): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer (Section G): GENZYME BIOSURGERY (RIDGEFIELD); 1125 pleasantview terrace; ridgefield NJ 07657
• Manufacturer Contact: darlene kadel ; 55 corporate drive, ms 55b-220; a; bridgewater, NJ 08807
• MDR Report Key: 8176324
• MDR Text Key: 130985511
• Report Number: 2246315-2018-00724
• Device Sequence Number: 1
• Product Code: MOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2021
• Device Lot Number: 8RSL028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability