MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-03-03 for CIRCUMCISION TRAY DYNDF1050A DJ29 manufactured by Medline Industries, Inc..
[1140341]
A circumcision was being performed. The tips of the hemostat did not fully approximate and the foreskin broke away. The area was sutured.
Patient Sequence No: 1, Text Type: D, B5
[8141888]
It was reported that during a circumcision of a newborn, the hemostat apparently slipped off and resulted in a tear of the foreskin. The area was sutured without further incident. There was no damage to the urethra. No further complication resulted and scarring was not anticipated. The sample was not released, but photos were taken. The photos illustrate that as the hemostat is in the locked position, the teeth do not fully touch at the top, which would explain the tissue slipping during the procedure. This separation is visually apparent. A root cause was not identified, as it was difficult to determine this with the photos.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1417592-2009-00013 |
| MDR Report Key | 1378907 |
| Report Source | 06 |
| Date Received | 2009-03-03 |
| Date of Report | 2009-02-27 |
| Date of Event | 2009-01-26 |
| Date Facility Aware | 2009-02-02 |
| Date Added to Maude | 2010-04-10 |
| 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 | 3 |
| Manufacturer Contact | LARA SIMMONS. |
| Manufacturer Street | ONE MEDLINE PL. |
| Manufacturer City | MUNDELEIN IL 60060 |
| Manufacturer Country | US |
| Manufacturer Postal | 60060 |
| Manufacturer Phone | 8478372759 |
| Manufacturer G1 | MEDLINE INDUSTRIES, INC. |
| Manufacturer Street | ONE MEDLINE PL. |
| 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 | HEMOSTAT WITHIN TRAY |
| Product Code | OHG |
| Date Received | 2009-03-03 |
| Model Number | DYNDF1050A |
| Catalog Number | DJ29 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2009-03-03 |