MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-05 for C-SECTION TRAY 50-13004 manufactured by Deroyal Industries.
[5826624]
Umbilical cord clamp in c-section cpt did not clamp all the way and another clamp was pulled separately.
Patient Sequence No: 1, Text Type: D, B5
[13436140]
Investigation findings: the customer was contacted on 10/30/2012. A lot number is not available and neither is the actual sample for the report. Due to the lack of info, a thorough investigation cannot be performed. Correction: credit was issued. Root cause analysis: undetermined, no sample or lot number provided. Corrective action and/or systemic correction action taken: none taken. Preventive action: none taken. This report is being filed due to a retrospective review of complaints. This complaint has been re-opened for further investigation. A supplemental report will be filed if further investigation provides info which changes the content of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2015-00014 |
| MDR Report Key | 4752175 |
| Report Source | 06 |
| Date Received | 2015-05-05 |
| Date of Report | 2015-05-01 |
| Date of Event | 2012-10-01 |
| Date Mfgr Received | 2012-10-29 |
| Date Added to Maude | 2015-06-16 |
| 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 Street | 200 DEBUSK LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | C-SECTION TRAY |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | FOD |
| Date Received | 2015-05-05 |
| Catalog Number | 50-13004 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 700 MARTIN LUTHER KING, JR. BLVD SANFORD FL 32771 US 32771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-05-05 |