MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-03-19 for IBP ULNA LEFT STD INTLK N/A 114368 manufactured by Biomet Uk Ltd..
[139162894]
(b)(4). Concomitant medical products: custom lt ibp med humeral comp, catalog #: cp560539, lot #: 750420. The investigation is in process. Once the investigation has been completed, a follow-up mdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[139162895]
Elbow revision due to unknown reasons.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 3002806535-2019-00293 |
MDR Report Key | 8431468 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2019-03-19 |
Date of Report | 2019-08-28 |
Date of Event | 2012-05-16 |
Date Mfgr Received | 2019-08-25 |
Device Manufacturer Date | 1997-06-13 |
Date Added to Maude | 2019-03-19 |
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 | MS. CHRISTINA ARNT |
Manufacturer Street | 56 E. BELL DR. |
Manufacturer City | WARSAW IN 46582 |
Manufacturer Country | US |
Manufacturer Postal | 46582 |
Manufacturer Phone | 5745273773 |
Manufacturer G1 | BIOMET UK LTD. |
Manufacturer Street | WATERTON INDUSTRIAL ESTATES |
Manufacturer City | BRIDGEND CF313XA |
Manufacturer Country | UK |
Manufacturer Postal Code | CF31 3XA |
Single Use | 3 |
Previous Use Code | 3 |
Removal Correction Number | N/A |
Event Type | 3 |
Type of Report | 3 |
Brand Name | IBP ULNA LEFT STD INTLK |
Generic Name | PROSTHESIS, ELBOW |
Product Code | JDB |
Date Received | 2019-03-19 |
Model Number | N/A |
Catalog Number | 114368 |
Lot Number | 221552 |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | * |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | BIOMET UK LTD. |
Manufacturer Address | WATERTON INDUSTRIAL ESTATES BRIDGEND CF313XA UK CF31 3XA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-03-19 |