MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2010-09-23 for CIRCUMCISION TRAY DYNDF1017A manufactured by Medline Industries, Inc..
[1477856]
It was reported that during a circumcision procedure, one of the clamps unhinged and the plastibell popped off, resulting in bleeding. The procedure was then converted to a gomco procedure.
Patient Sequence No: 1, Text Type: D, B5
[8705352]
It was reported via mail that while performing a circumcision, a clamp from the tray unhinged. Bleeding resulted. The procedure was then completed utilizing the gomco method. Multiple attempts have been made to contact the facility but no response has been received. No sample has been returned for eval. This is a custom tray that the customer has been using for more than 3 years. There have been no previous complaints from this customer for this tray or this issue. The tray has three forceps, two straight and one mosquito. The component of concern was not identified in the report by the customer. The extent of injury to the pt is not known. The issue has not been confirmed and a root cause has not been determined.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2010-00058 |
| MDR Report Key | 1844928 |
| Report Source | 06 |
| Date Received | 2010-09-23 |
| Date of Report | 2010-09-17 |
| Date of Event | 2010-07-29 |
| Date Facility Aware | 2010-08-20 |
| Date Mfgr Received | 2010-08-20 |
| Date Added to Maude | 2012-03-14 |
| 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 | 3 |
| Manufacturer Contact | LARA SIMMONS |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PLACE |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60060 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIRCUMCISION TRAY |
| Generic Name | NONE |
| Product Code | OHG |
| Date Received | 2010-09-23 |
| Model Number | DYNDF1017A |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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. Required No Informationntervention | 2010-09-23 |