MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ STERI-STRIP¿ REINFORCED SKIN CLOSURES; STERI-STRIP SKIN CLOSURES

Model Number N/A

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

Patient Problem Skin Erosion (2075)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Patient information: information was not provided.Lot #: the product lot number was unknown.

Event Description

A hospital in france (b)(6) r1547 3m¿ steri-strip¿ reinforced skin closures were applied to a patient's incision following an abdominoplasty.The hospital alleged the patient experienced a phlycten (blister) and desepidermization.The steri-strip¿ reinforced skin closures were reportedly difficult to remove.The patient allegedly required a prolonged hospitalization for observation.

• Brand Name: 3M¿ STERI-STRIP¿ REINFORCED SKIN CLOSURES
• Type of Device: STERI-STRIP SKIN CLOSURES
• 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: dianne gibbs ; 3m center building 275-5w-06; st. paul, MN 55144 ; 6517379117
• MDR Report Key: 8433112
• MDR Text Key: 139218532
• Report Number: 2110898-2019-00041
• Device Sequence Number: 1
• Product Code: KGX
• UDI-Device Identifier: 30707387023646
• UDI-Public: 30707387023646
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• 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: R1547
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2019
• 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
• Patient Outcome(s): Hospitalization