MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-29 for BLADE, SURGICAL CLIPPER, STANDARD PREP CAH4406D manufactured by Jiangsu Better Electric.
[79031122]
No lot number or sample were provided for this complaint.? The device history record for the past three months for this product was reviewed and no abnormalities were found. The device master record was also reviewed and there have been no changes to the product since the product launch. ? The reserved sample (lot # g1716-sh) was tested and everything was within the specifications. ? As a sample involved in the reported incident was not available for further investigation, the root cause could not be determined at this time. ? Based on the limited information provided, no additional action taken will be taken at this time. We will continue to monitor for any similar reports.
Patient Sequence No: 1, Text Type: N, H10
[79031123]
Grey clipper head for hair removal caused razor burn to patient's groin causing bleeding and required a dressing on the site.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423537-2017-00113 |
| MDR Report Key | 6676642 |
| Date Received | 2017-06-29 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-06-06 |
| Date Facility Aware | 2017-06-07 |
| Report Date | 2017-06-20 |
| Date Reported to Mfgr | 2017-06-20 |
| Date Mfgr Received | 2017-06-07 |
| Date Added to Maude | 2017-06-29 |
| 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 | PATRICIA TUCKER |
| Manufacturer Street | 1500 WAUKEGAN RD |
| Manufacturer City | WAUKEGAN IL 60085 |
| Manufacturer Country | US |
| Manufacturer Postal | 60085 |
| Manufacturer G1 | JIANGSU BETTER ELECTRIC |
| Manufacturer Street | 11 HUI HAI RD. BIN HAI ZONE, QI DONG |
| Manufacturer City | JIANG SU 226200 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 226200 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BLADE, SURGICAL CLIPPER, STANDARD PREP |
| Generic Name | RAZOR, SURGICAL |
| Product Code | LWK |
| Date Received | 2017-06-29 |
| Model Number | CAH4406D |
| Catalog Number | CAH4406D |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU BETTER ELECTRIC |
| Manufacturer Address | 11 HUI HAI RD. BIN HAI ZONE, QI DONG JIANG SU 226200 CH 226200 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-06-29 |