MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-31 for RULER 71674079 manufactured by Smith & Nephew, Inc..
[125746944]
Patient Sequence No: 1, Text Type: N, H10
[125746945]
It was reported that during surgery the silver tip of the ruler detached and remained on the patient. Delay of less than 30min reported. Additional incisions required to remove pieces. All pieces accounted for. No back up reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1020279-2018-02300 |
| MDR Report Key | 8024797 |
| Date Received | 2018-10-31 |
| Date of Report | 2018-12-18 |
| Date of Event | 2018-10-05 |
| Date Mfgr Received | 2018-10-05 |
| Device Manufacturer Date | 2016-04-19 |
| Date Added to Maude | 2018-10-31 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal | 38116 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 1450 BROOKS ROAD |
| Manufacturer City | MEMPHIS TN 38116 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 38116 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | RULER |
| Generic Name | TAPE, MEASURING, RULERS AND CALIPERS |
| Product Code | FTY |
| Date Received | 2018-10-31 |
| Catalog Number | 71674079 |
| Lot Number | 16BCT0003 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 1450 BROOKS ROAD MEMPHIS TN 38116 US 38116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-10-31 |