MAUDE Adverse Event Report: JOHNSON & JOHNSON CONSUMER INC BAB SHEER PLASTIC EXTRA LARGE 10S USA 381370057055; ADHESIVE BANDAGE

Model Number 381370057055

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

Patient Problems Ulcer (2274); No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Device was used for treatment, not diagnosis.(b)(4), lot number = ni, exp date: na.Device is not expected to be returned for manufacturer review/investigation.Concomitant medical products: consumer still on drugs for following concomitant medical products and therapy dates: gabapentin300mg 3x per day, flomax, prazosin 4mg, propranolol 10mg 3x per day, kcl 10meq 2 tablets 2x per day, furosemide, pravastatin, famotidine prn, omeprazole 20mg 1x per day, baclofen 10mg 3xper day, albuterol, atenolol 100 2x per day, allopurinol, magnesium 500mg 2x per day, metformin 500mg 2 tabs qd at supper, imdur, nitroglycerin sl, zonisamide 50mg, melatonin, asa 81 1x per day, nifedipine 2x per day, mtv 1x per day, iron.Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.(b)(4).This is two of two medwatches being submitted as consumer reported adverse events for both left and right foot.See medwatch 8041154-2019-00067 (left foot) and 8041154-2019-00068 (right foot).The same patient is represented in each medwatch.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Consumer reported the bab sheer plastic extra large 10s usa 381370057055 gushed blood on his right foot after a hammer toe surgery and the layers came off the week before last.Additionally, consumer reported there was hidden ulcer formation under the skin that helped this happen which was from the adhesive of band-aid.Consumer sought medical attention from health care provider and was prescribed medication.The symptoms have not resolved.This is two of two medwatches being submitted as consumer reported adverse events for both left and right foot.See medwatch 8041154-2019-00067 (left foot) and 8041154-2019-00068 (right foot).The same patient is represented in each medwatch.

• Brand Name: BAB SHEER PLASTIC EXTRA LARGE 10S USA 381370057055
• Type of Device: ADHESIVE BANDAGE
• Manufacturer (Section D): JOHNSON & JOHNSON CONSUMER INC; 199 grandview rd; skillman NJ 08558 9418
• Manufacturer (Section G): BRAZIL CONSUMER; rodovia presidente dutra km 15; são josé dos campos ; BR
• Manufacturer Contact: linda plews ; 199 grandview rd; skillman, NJ 08558-9418 ; 2152737120
• MDR Report Key: 8832766
• MDR Text Key: 152471713
• Report Number: 8041154-2019-00068
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 381370057055
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 105