MAUDE Adverse Event Report: 3M HEALTH CARE 3M TEGADERM DRESSING

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

Patient Problem Cellulitis (1768)

Event Date 02/13/2017

Event Type  Injury  

Manufacturer Narrative

Customer did not provide product catalog or lot number.Customer reported an unknown spray was also applied to the incision sites before application of the tegadem dressings.

Event Description

Female customer reported she had a xlif procedure for a spinal fusion.She had three incisions, two on her side (flank) and one on her back.She alleged an unknown spray and tegaderm dressings (unknown catalog, lot number) were applied to each site.She allegedly experienced an allergic reaction (itching, redness, blistering and weeping) where the dressings were applied.The reactions reportedly developed into cellulitis and she reported being treated with prednisone, keflex, bactrim and doxycycline.The reactions were reportedly resolving and healing well.She reported a history of three previous (b)(6), skin sensitivity and previous reactions to tape, band-aids and adhesives.

• Brand Name: 3M TEGADERM DRESSING
• Type of Device: TEGADERM DRESSING
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144
• Manufacturer (Section G): 3M COMPANY BROOKINGS; 601 22nd ave south; brookings SD 57006
• Manufacturer Contact: karen krenik ; 3m center; building 0275-05-w-06; st. paul, MN 55144 ; 6517333091
• MDR Report Key: 6399345
• MDR Text Key: 69798852
• Report Number: 2110898-2017-00029
• Device Sequence Number: 1
• Product Code: NAD
• 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: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/27/2017
• 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
• Treatment: SPRAY -UNSPECIFIED
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR