MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-26 for CLAMP, CIRCUMCISION SSI-0034 manufactured by Medline.
[101242882]
It was reported that the circumcision clamp was noted to have metal flakes on it when open for use. Was not used on pt. Cardinal cat #ssi-0034, lot #804822.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5075543 |
| MDR Report Key | 7299667 |
| Date Received | 2018-02-26 |
| Date of Report | 2018-02-23 |
| Date of Event | 2018-02-22 |
| Date Added to Maude | 2018-02-27 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | ATTORNEY |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CLAMP, CIRCUMCISION |
| Generic Name | CIRCUMCISION CLAMP |
| Product Code | HFX |
| Date Received | 2018-02-26 |
| Catalog Number | SSI-0034 |
| Lot Number | 804822 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-26 |