MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-21 for MORSE STERNAL RETRACTOR ADULT 8" 341162 manufactured by Teleflex.
[3978817]
Customer called to report that the hook on the device broke after the procedure was completed. There was no patient injury. Patient current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[11453010]
The device sample was not received by the manufacturer in time for this report.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 1044475-2013-00195 |
MDR Report Key | 3537224 |
Report Source | 06 |
Date Received | 2013-10-21 |
Date of Report | 2013-10-07 |
Date of Event | 2013-10-07 |
Date Mfgr Received | 2013-10-07 |
Date Added to Maude | 2014-01-23 |
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 | ELAINE BURKLE, RN |
Manufacturer Street | PO BOX 12600 |
Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
Manufacturer Country | US |
Manufacturer Postal | 27709 |
Manufacturer Phone | 9194334957 |
Manufacturer G1 | TELEFLEX |
Manufacturer Street | 2917 WECK DR. |
Manufacturer City | RESEARCH TRIANGLE PARK NC 27709 |
Manufacturer Country | US |
Manufacturer Postal Code | 27709 |
Single Use | 3 |
Previous Use Code | 3 |
Event Type | 3 |
Type of Report | 3 |
Brand Name | MORSE STERNAL RETRACTOR ADULT 8" |
Generic Name | STERNAL RETRACTOR |
Product Code | EIG |
Date Received | 2013-10-21 |
Catalog Number | 341162 |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX |
Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2013-10-21 |