MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-09-04 for PILLING COOLEY STERNAL RETRACTOR ADULT 341194 manufactured by Teleflex.
[16011419]
The event is reported as: alleged issue: during use on the pt in operating room, the retractor got loose gradually without being noticed and the opened abdomen part of the pt was suddenly closed. No reported injury.
Patient Sequence No: 1, Text Type: D, B5
[16510032]
The device sample was not received by the mfr at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1044475-2013-00142 |
| MDR Report Key | 3371285 |
| Report Source | 05,06 |
| Date Received | 2013-09-04 |
| Date of Report | 2013-08-16 |
| Date of Event | 2013-08-14 |
| Date Mfgr Received | 2013-08-16 |
| Date Added to Maude | 2013-12-04 |
| 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 | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334957 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | 2917 WECK DR. |
| Manufacturer City | RTP 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 COOLEY STERNAL RETRACTOR ADULT |
| Generic Name | STERNAL RETRACTOR |
| Product Code | EIG |
| Date Received | 2013-09-04 |
| Catalog Number | 341194 |
| Lot Number | QQ9 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 2013-09-04 |