SCARAWAY SIL PATCH 1.5 X 3 IN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2016-12-08 for SCARAWAY SIL PATCH 1.5 X 3 IN manufactured by Bio Med Sciences, Inc.

Event Text Entries

[61812361] Consumer had surgery on her achilles tendon on unknown date (b)(6) 2016. She was seen by her orthopedic surgeon on (b)(6) 2016 and was advised she could use the scaraway silicone sheets. She purchased the scaraway sheets from her local (b)(6) and this was the first time using the silicone sheets. She started use of the scaraway sheets on possibly (b)(6) 2016. She had the sheet on for approximately 3 hours before she began itching on (b)(6) 2016 and would have to remove the sheets. She then started wearing the scaraway sheets for about 3 hours and then take off due to the itching and did this until approximately (b)(6) 2016. She decided to discontinue use of the scaraway sheet for a couple of days. The itching resolved when she discontinued the scaraway sheets on (b)(6) 2016. She restarted using 1 silicone scaraway sheet on approximately (b)(6) 2016 and wore again for 3 hours and stopped use on approximately (b)(6) 2016. She again experienced the itching while using the scaraway on (b)(6) 2016. When she looked at the area, it was red and inflamed and she was unsure when this issue first appeared, so it started on unknown (b)(6) 2016. She went to her regular doctor on (b)(6) 2016 and told him she felt she had a chemical burn, left foot swelling and infection to her surgical site. She was put on macrobid and possibly floxicam (she thinks it was an antibiotic but this medication is anti-inflammatory drug). She was seen by her orthopedic surgeon on (b)(6) 2016 and was given a ct scan to rule out infection in joint or bone. The ct scan showed fluid under the scar area and abscess. The scar on approximately (b)(6) 2016 has split across and not down the incision site where fluid was draining and it was bleeding. She was started on bactrim again to treat the issues. On (b)(6) 2016 she was seen by her doctor and was started on another round of bactrim. She followed up with her regular doctor on (b)(6) 2016 and they ordered an ultra sound on her left ankle which showed abscess and infection in the scar area on her left leg. She had another appointment on (b)(6) 2016 and they discussed having an mri. She was prescribed silvadene cream to use on her burn every 4 hours and to leave open to air. She was also prescribed a lidocaine 2. 5% and prilocaine 2. 5% cream for pain. She did not start using the creams until (b)(6) 2016 due to delay with insurance. She had an mri on (b)(6) 2016 and was started on bactrim again. She had an appointment with her regular doctor on (b)(6) 2016 and since her areas are not better she was referred to emergency room so they could drain the area and start her on iv antibiotics. She went to local emergency room on (b)(6) 2016. She had blood work drawn but results are pending. The orthopedic doctor on call at emergency room did not want to treat without getting a culture and see what was going on with her ankle. She was scheduled to go hospital on (b)(6) 2016 where she will have her left ankle area debrided, a drain will be placed for 2 days and then she will have a picc line placed for iv antibiotics (3-4 weeks of antibiotics). Then they will see if they can close the incision without having to send her to another hospital in (b)(6). She advised the chemical burn is almost gone but is still ongoing. She is allergic to sulfa drugs and has a history of arthritis and achilles tendon surgery. Concomitant medications include: celebrex. She is (b)(6).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1811666-2016-00006
MDR Report Key6155722
Report SourceCONSUMER
Date Received2016-12-08
Date of Report2016-11-22
Date of Event2016-09-28
Date Mfgr Received2016-11-10
Device Manufacturer Date2016-01-07
Date Added to Maude2016-12-08
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactDR. ANTHONY FARAGASSO
Manufacturer Street515 EASTERN AVE.
Manufacturer CityALLEGAN MI 49010
Manufacturer CountryUS
Manufacturer Postal49010
Manufacturer Phone2696863805
Manufacturer G1BIO MED SCIENCES, INC.
Manufacturer Street7854 MORRIS COURT
Manufacturer CityALLENTOWN PA 18106
Manufacturer CountryUS
Manufacturer Postal Code18106
Single Use3
Remedial ActionOT
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSCARAWAY SIL PATCH 1.5 X 3 IN
Generic NameELASTOMER; SILICONE, FOR SCAR MANAGEMENT
Product CodeMDA
Date Received2016-12-08
Lot NumberC0281
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBIO MED SCIENCES, INC
Manufacturer Address7584 MORRIS COURT SUITE 218 ALLENTOWN PA 18106 US 18106


Patients

Patient NumberTreatmentOutcomeDate
101. Other; 2. Required No Informationntervention 2016-12-08

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