MAUDE Adverse Event Report: 3M DEUTSCHLAND GMBH SCOTCHBOND UNIVERSAL ADHESIVE; AGENT, TOOTH BONDING, RESIN

Catalog Number 41258

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

Patient Problem Anaphylactic Shock (1703)

Event Type  Injury  

Manufacturer Narrative

Engineering investigation was limited due to lack of returned product and lot number information.This event involved two 3m espe medical devices, therefore two manufacturer medwatch reports are being submitted.This medwatch report provides information on the first medical device.Manufacturer report 3005174370-2016-00031 provides information on the second medical device.Both 3m subject products have been evaluated for biocompatibility and are safe for their intended use.Without additional information on patient medical history, the cause of the reported reaction cannot be determined.In four years of clinical history with scotchbond universal adhesive, there are no other reports of this nature.

Event Description

A medical office reported a (b)(6) year-old patient experienced anaphylactic shock after use of 3m espe scotchbond universal adhesive and 3m espe relyx luting plus automix cement.Contact information for the medical office was inadvertently not obtained during the call.3m contacted the treating dental office and they were unable to identify the patient involved in this case; therefore no further information is available, and the relationship of the symptoms reported to use of the 3m subject products cannot be established.

• Brand Name: SCOTCHBOND UNIVERSAL ADHESIVE
• Type of Device: AGENT, TOOTH BONDING, RESIN
• Manufacturer (Section D): 3M DEUTSCHLAND GMBH; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• Manufacturer (Section G): 3M DEUTSCHLAND GMBH-SEEFELD; espe platz; seefeld, D8222 9; GM D82229
• Manufacturer Contact: thomas meindl ; carl-schurz-strabe 1; neuss, 41453 ; GM 41453
• MDR Report Key: 5490376
• MDR Text Key: 40016575
• Report Number: 9611385-2016-00003
• Device Sequence Number: 1
• Product Code: KLE
• Combination Product (y/n): N
• PMA/PMN Number: K110302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial
• Report Date: 02/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Dentist
• Device Catalogue Number: 41258
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 59 YR