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 |