MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2013-10-02 for CIRCUMCISION TRAY DYNDF1091 manufactured by Medline Industries, Inc..
[18306989]
During a circumcision, the pt suffered a 1cm abrasion to the penis that was thought to have been caused by the clamp.
Patient Sequence No: 1, Text Type: D, B5
[18670866]
The infant sustained a 1 cm abrasion to his penis during the procedure that was thought to have been caused by the circumcision clamp. The clinician stated that they dabbed the blood with gauze and it stopped almost immediately and did not require any intervention. The clamp was returned but not the rod section of the device. The sample was evaluated. There were no sharp edges or burrs noted on the device. No manufacturing defect was identified. A root cause for the reported incident was not determined. We have had no other complaints for this kit in the past two years.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2013-00073 |
| MDR Report Key | 3397312 |
| Report Source | 05,06 |
| Date Received | 2013-10-02 |
| Date of Report | 2013-09-27 |
| Date of Event | 2013-08-29 |
| Date Mfgr Received | 2013-08-30 |
| Device Manufacturer Date | 2012-07-01 |
| Date Added to Maude | 2013-10-10 |
| 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 | JULIE FINLEY |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8476434709 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCUMCISION TRAY |
| Product Code | OHG |
| Date Received | 2013-10-02 |
| Catalog Number | DYNDF1091 |
| Lot Number | 12HB2013 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | MUNDELEIN IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-10-02 |