MAUDE Adverse Event Report: 3M HEALTH CARE 3M RED DOT(TM) MONITORING ELECTRODE; ECG ELECTRODES

Model Number N/A

Device Problem Missing Value Reason (3192)

Patient Problems Cellulitis (1768); Unspecified Infection (1930)

Event Date 05/26/2016

Event Type  Injury  

Manufacturer Narrative

The reporter did not provide her weight only her age.No lot number was provided.Without the lot number it is no possible to determine the manufacturer date or expiration date.The reporter did not provide an e-mail address.Product was not returned and it is not possible to investigate or pull retains.End of report.

Event Description

A female alleged she had a colonoscopy procedure in late (b)(6) 2016.She stated that four 3m red dot¿ electrodes were placed on her skin - 2 on her stomach and 2 on her chest.She did not know if any skin preparation was applied because she was sedated for the procedure.After the procedure she alleged redness where one of the electrodes had been on her chest.No skin issues was noted under the other three electrode sites.She alleged that the red area was in a picture frame shape.The area allegedly became raised and itchy.She alleged that the area spread.She went to the emergency room and was allegedly diagnosed with cellulitis.She stated an oral antibiotic was prescribed.The cellulitis resolved with only a small amount of redness remaining two weeks later.The woman is not a diabetic and does not take blood thinner medication, and has not had issues with medical tape or bandages.

• Brand Name: 3M RED DOT(TM) MONITORING ELECTRODE
• Type of Device: ECG ELECTRODES
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M CANADA COMPANY; 400 route 100; morden, manitoba R6M 1 Z9; CA R6M 1Z9
• Manufacturer Contact: linda johnsen ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6517374376
• MDR Report Key: 5765797
• MDR Text Key: 48670986
• Report Number: 2110898-2016-00071
• Device Sequence Number: 1
• Product Code: DRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 2560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 69 YR