MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 1999-04-20 for HOOKS manufactured by Synthes (usa).
[132099]
The subject devices were implanted on 3/1/99. On 3/20/99, while the pt was bending to vomit, the subject devices came loose from the concomitant devices. On 3/22/99, another surgery was performed to remove the subject devices and replace with new devices.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 2520274-1999-00022 |
MDR Report Key | 219474 |
Report Source | 05,06,07 |
Date Received | 1999-04-20 |
Date of Report | 1999-03-23 |
Date of Event | 1999-03-20 |
Date Mfgr Received | 1999-03-23 |
Date Added to Maude | 1999-04-21 |
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 | 0 |
Health Professional | 3 |
Initial Report to FDA | 3 |
Report to FDA | 3 |
Event Location | 0 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | NI |
Generic Name | HOOKS |
Product Code | HNQ |
Date Received | 1999-04-20 |
Returned To Mfg | 1999-04-06 |
Model Number | NA |
Catalog Number | NI |
Lot Number | NI |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Eval'ed by Mfgr | Y |
Implant Flag | Y |
Date Removed | V |
Device Sequence No | 1 |
Device Event Key | 212843 |
Manufacturer | SYNTHES (USA) |
Manufacturer Address | 1690 RUSSELL RD. PAOLI PA 19301 US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 1999-04-20 |