MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 03 report with the FDA on 2008-03-27 for 3M ESPE STAINLESS STEEL CROWNS UNK manufactured by 3m Espe Dental Products.
[17373958]
As described in a case report from the pediatric dentistry, v30: no. 1, dated jan/feb, 2008: a pediatric patient aspirated a stainless steel crown (ssc), reportedly from 3m espe, st. Paul, mn. After fitting and prior to cementation, the crown became dislodged distally behind the throat pack into the patient's airway. At the time of aspiration, the patient was sedated and immobilized, lying in a supine position. A diagnosis of foreign body aspiration (fba) was made. A pediatric surgeon performed a diagnostic laryngoscopy with rigid bronchoscopy under general anesthesia to retrieve the foreign body. The surgery was uneventful, and the patient was discharged home the same day. Please refer to the attached case report from the pediatric dentistry, v30:no. 1, dated jan/feb, 2008 for complete details. Sedation: 10 mg (0. 6 mg/kg) of midazolam with 50 mg (3mg/kg) of hydroxyzine was given orally.
Patient Sequence No: 1, Text Type: D, B5
[17641963]
Method, results and conclusions: device was not returned to 3m; therefore, no evaluation was conducted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2110898-2008-00006 |
| MDR Report Key | 1020653 |
| Report Source | 03 |
| Date Received | 2008-03-27 |
| Date of Report | 2008-03-25 |
| Date Mfgr Received | 2008-03-13 |
| Date Added to Maude | 2008-04-03 |
| 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 | CAROLYN KRAMPE |
| Manufacturer Street | 3M CENTER, BLDG. 275-2W-08 |
| Manufacturer City | ST. PAUL MN 551441000 |
| Manufacturer Country | US |
| Manufacturer Postal | 551441000 |
| Manufacturer Phone | 6517361148 |
| Manufacturer G1 | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Street | 211 MCGAW AVENUE |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M ESPE STAINLESS STEEL CROWNS |
| Generic Name | STAINLESS STEEL CROWNS |
| Product Code | ELZ |
| Date Received | 2008-03-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 988746 |
| Manufacturer | 3M ESPE DENTAL PRODUCTS |
| Manufacturer Address | 211 MCGAW AVENUE IRVINE CA 92614 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2008-03-27 |