MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2016-06-09 for RELYX U200 CEMENT 56878 manufactured by 3m Deutschland Gmbh.
[47090343]
The product is expected to be returned to 3m for evaluation. If the sample is returned and evaluation results become available, a follow-up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[47090344]
On (b)(6) 2016, a dentist from (b)(6) reported to 3m that a patient was recommended for endodontic treatment. This patient experienced persistent sensitivity (for approximately 2 months) following placement of a crown (manufacturer unknown) using 3m epse relyx u200 cement (also known as relyx unicem 2 cement).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2016-00007 |
| MDR Report Key | 5710921 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2016-06-09 |
| Date of Report | 2016-07-14 |
| Date Mfgr Received | 2016-07-14 |
| Date Added to Maude | 2016-06-09 |
| 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-STRABE 1 |
| Manufacturer City | NEUSS, 41453 |
| Manufacturer Country | GM |
| Manufacturer Postal | 41453 |
| Manufacturer G1 | 3M DEUTSCHLAND GMBH-SEEFELD |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD, D82229 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | D82229 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX U200 CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMA |
| Date Received | 2016-06-09 |
| Returned To Mfg | 2016-07-06 |
| Catalog Number | 56878 |
| Lot Number | 590933 |
| Device Expiration Date | 2016-10-01 |
| Operator | DENTIST |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M DEUTSCHLAND GMBH |
| Manufacturer Address | CARL-SCHURZ-STRABE 1 NEUSS, 41453 GM 41453 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-06-09 |