AQUACEL AG SURGICAL DRESSING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for AQUACEL AG SURGICAL DRESSING manufactured by Convatec, Inc..

Event Text Entries

[181365671] My wife, (b)(6), has total knee replacement (right knee) on (b)(6) 2019. Three days later she had burning sensation and went back to the dr. The dr removed the aquacel surgical hydrofiber dressing and the skin on either side of the incision looked like 3rd degree burns from the dressing adhesive. My wife was in tremendous pain. (both burning sensation and actual pain). The dr was shocked. He had never seen this before from this dressing that he has used many times. He even took pictures. Because of this he no longer uses this product. He also contacted the mfr (aquacel) and they claimed that my wife was allergic to the adhesive or she bent her knee too much. First of all the knee is supposed to be bent as much as possible after this type of surgery. Also my wife has never had a problem with any adhesive. After contact will the knee care coord and the pt safety director, the hosp sent us a letter stating that they will no longer be using this dressing. After contacting several law firms with no results. It was suggested that we contact the fda. Thus this post. The dr prescribed ointments which helped very little. Also pain pills which helped very little. My wife hadn't been able to sleep until recently. She also went to a pain specialist and he said that the nerve endings were damaged but were finally healing. My wife's name is (b)(6). Address is (b)(6), phone# (b)(6), email: (b)(6). Fda safety report id# (b)(4).
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5093254
MDR Report Key9750748
Date Received2020-02-24
Date of Report2020-02-20
Date of Event2019-11-18
Date Added to Maude2020-02-25
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAQUACEL AG SURGICAL DRESSING
Generic NameDRESSING, WOUND, DRUG
Product CodeFRO
Date Received2020-02-24
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCONVATEC, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2020-02-24

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