MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2019-03-08 for TERUMO DENTAL NEEDLE DN-3116KL manufactured by Terumo Corporation - Kofu.
[138297051]
Patient identifier - requested but not yet provided. Age & date of birth - requested but not yet provided. Sex - requested but not yet provided. Weight - requested but not yet provided. Ethnicity -requested but not yet provided. Race - requested but not yet provided. Date of event: requested but not yet provided. Expiration date - requested but not yet provided. Udi - the corresponding lot is not subjected for udi. Implanted date: device was not implanted. Explanted date: device was not explanted. Establishment name: requested but not yet provided. Health professional- requested but not yet provided. Occupation - requested but not yet provided. Device manufacture date - requested but not yet provided. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[138297052]
The user facility reported that the terumo dental needle was damaged.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681835-2019-00010 |
| MDR Report Key | 8405735 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-03-08 |
| Date of Report | 2019-03-08 |
| Date of Event | 2019-02-08 |
| Date Mfgr Received | 2019-03-04 |
| Date Added to Maude | 2019-03-08 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARK VORNHEDER |
| Manufacturer Street | 950 ELKTON BLVD. |
| Manufacturer City | ELKTON MD 21921 |
| Manufacturer Country | US |
| Manufacturer Postal | 21921 |
| Manufacturer Phone | 8002837866 |
| Manufacturer G1 | TERUMO CORPORATION - KOFU |
| Manufacturer Street | REG. NO. 9681835 1727-1, TSUIJI-ARAI, SHOWA-CHO |
| Manufacturer City | NAKAKOMA-GUN, YAMANASHI 409-3853 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 409-3853 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUMO DENTAL NEEDLE |
| Generic Name | NEEDLE, DENTAL |
| Product Code | DZM |
| Date Received | 2019-03-08 |
| Model Number | NA |
| Catalog Number | DN-3116KL |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION - KOFU |
| Manufacturer Address | 1727-1, TSUIJI-ARAI SHOWA-CHO NAKAKOMA-GUN, YAMANASHI 409-3853 JA 409-3853 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2019-03-08 |