MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2013-01-03 for PILLING LEMOLE-PILL VALVE RET SET #1 341501 manufactured by Teleflex.
[19998975]
The event is reported as: alleged issue: customer alleges that the clamps wouldn't stay tight during a procedure. Staff had to keep re-tightening the clamps. No pt injury reported. Pt current condition is fine.
Patient Sequence No: 1, Text Type: D, B5
[20166746]
Sample received my mfr, but investigation is incomplete at time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2013-00001 |
| MDR Report Key | 2901473 |
| Report Source | 06,07 |
| Date Received | 2013-01-03 |
| Date of Report | 2012-12-11 |
| Date of Event | 2012-12-06 |
| Date Mfgr Received | 2012-12-11 |
| Date Added to Maude | 2013-03-27 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| 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 | PILLING LEMOLE-PILL VALVE RET SET #1 |
| Generic Name | RETRACTOR |
| Product Code | EIG |
| Date Received | 2013-01-03 |
| Returned To Mfg | 2012-12-13 |
| Catalog Number | 341501 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-01-03 |