MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-06-13 for 3M ESPE IMPRINT 4 PRELIMINARY PENTA SQ 71521 manufactured by 3m Deutschland Gmbh.
[77498304]
On (b)(6) 2017, 3m was notified that a (b)(6) female experienced gastro-intestinal irritation that resulted in hospitalization following an impression procedure with 3m espe imprint 4 preliminary penta sq. The impression procedure was performed on (b)(6) 2016. 3m received further information on (b)(6) 2017, that the patient gagged during the impression procedure and that the dental assistant swept the patient's mouth for material, but no residual impression material was found in the patient's mouth; the patient had surgery on (b)(6) 2016, for a bowel obstruction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2017-00007 |
| MDR Report Key | 6639136 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-06-13 |
| Date of Report | 2017-05-17 |
| Date of Event | 2016-05-14 |
| Date Mfgr Received | 2017-05-17 |
| Date Added to Maude | 2017-06-13 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR. THOMAS MEINDL |
| Manufacturer Street | CARL-SCHURZ-STRASSE 1 |
| Manufacturer City | NEUSS, 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH-SEEFELD |
| Manufacturer Street | 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 | 3M ESPE IMPRINT 4 PRELIMINARY PENTA SQ |
| Generic Name | IMPRESSION MATERIAL |
| Product Code | ELW |
| Date Received | 2017-06-13 |
| Catalog Number | 71521 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | CARL-SCHURZ-STRASSE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2017-06-13 |