MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-06-26 for ADSN TISS FCPS 4-3/4 1X2 6-120 manufactured by Integra York, Pa Inc..
[18070526]
Customer initially reports teeth broke while treating pt. On (b)(6) 2014, customer reports tip from the one tooth side of forcep broke off in pt lip when a biopsy was being taken. Tip was removed easily. No harm to pt. Event date not available, (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[18428143]
To date, the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 2523190-2014-00047 |
MDR Report Key | 3958804 |
Report Source | 06 |
Date Received | 2014-06-26 |
Date of Report | 2014-06-12 |
Date of Event | 2014-06-02 |
Date Mfgr Received | 2014-06-13 |
Date Added to Maude | 2014-08-01 |
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 | 0 |
Event Location | 0 |
Manufacturer Contact | SANDRA LEE |
Manufacturer Street | 315 ENTERPRISE DR |
Manufacturer Phone | 6019366828 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | ADSN TISS FCPS 4-3/4 1X2 |
Generic Name | M5-GENERAL SURGERY |
Product Code | EKD |
Date Received | 2014-06-26 |
Catalog Number | 6-120 |
Lot Number | UNK |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | INTEGRA YORK, PA INC. |
Manufacturer Address | YORK PA 17402 US 17402 |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2014-06-26 |