MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-15 for POLYETHER ADHESIVE 30600 manufactured by 3m Espe Ag.
[1336566]
Following a crown preparation procedure which utilized several 3m espe products, a patient experienced hives and breathing difficulty. The 3m espe products include: 3m espe protemp plus temporization material, 3m espe position penta quick vinyl polysiloxane preliminary impression material, 3m espe impregum penta soft quick step polyether impression material, and 3m espe polyether adhesive. Other non-3m espe products reported to have been used in the procedure include: septocaine, gingi-pak soaked in hemodent and temp bond. The patient sought treatment at an emergency room; reported treatment included administration of intravenous steroids and famotidine (pepcid). The patient was released later the same evening and was given a prescription for oral steroids and famotidine. The patient reported to be currently in good condition. No additional information on the situation is available at this time; 3m espe will continue to investigate.
Patient Sequence No: 1, Text Type: D, B5
[8661630]
Results and conclusions: the 3m espe impression materials (position penta quick, impregum penta soft quick step, impregum soft quick step, and polyether adhesive) were discarded following the procedures and no sample or lot number is available. The sample of protemp plus has been returned to the manufacturer for analysis. Based on current complaint history, reports of reaction to polyether impression materials are rare; approximately 2 reactions (of any nature) are reported per million product applications. While this number is low, 3m espe ag takes all allegations seriously and has searched for root causes or contributing factors that may have let to a reaction. Actions taken to date to identify potential causes include: cooperating with a dental university to conduct dentist-to-dentist follow-up of reaction allegations (our experience indicates that information may flow more freely between dentists that from dentist to manufacturer), chemically analyzing returned product when it is available, conducting additional irritation testing of product and components and reviewing product composition with toxicology experts. No common cause or factor has been identified to date. Based on our evaluation of biocompatibility and clinical history, the products are safe for its intended use. Manufacturer report numbers: 9611385-2010-00001: impregum penta soft quick step. 9611385-2010-00002: impregum soft quick step. 9611385-2010-00003: position penta quick. 9611385-2010-00005: protemp plus.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9611385-2010-00004 |
| MDR Report Key | 1646626 |
| Report Source | 05 |
| Date Received | 2010-03-15 |
| Date of Report | 2010-02-16 |
| Date of Event | 2010-02-09 |
| Date Mfgr Received | 2010-02-16 |
| Date Added to Maude | 2010-04-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DR. DEIS SOERGIARTO |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| Manufacturer Phone | 1527001169 |
| Manufacturer G1 | 3M ESPE AG |
| Manufacturer Street | 3M ESPE PLATZ |
| Manufacturer City | SEEFELD 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | POLYETHER ADHESIVE |
| Generic Name | POLYETHER ADHESIVE |
| Product Code | EBH |
| Date Received | 2010-03-15 |
| Model Number | NA |
| Catalog Number | 30600 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M ESPE AG |
| Manufacturer Address | ESPE PLATZ SEEFELD 82229 GM 82229 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-03-15 |