MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-24 for MCCARTNEY TUBE 35-TV manufactured by Surgi Supplies.
[83608431]
Patient Sequence No: 1, Text Type: N, H10
[83608432]
Device details: device description: mccartney tube?. Device code/identifier: 35-tv. Lot/batch: 3522116. Patient details: (b)(6) female with endometrial cancer. Prior surgery unknown and not provided following our request. Description of event: during total laparoscopic hysterectomy (tlh) using the mccartney tube? , a small vaginal laceration was found on the palatal vagina which required intervention for wound closure. Details from surgeon: "difficulty in treatment was anticipated beforehand and patient's tissue was in a more vulnerable state than usual. Since it was a malignant disease, we wanted to select manipulation in the tube. If not this device with material flexibility, it was probably difficult to keep the laceration within the proximal part of vagina, and make the recovery possible"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008254127-2017-00002 |
| MDR Report Key | 6819289 |
| Date Received | 2017-08-24 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-06-28 |
| Report Date | 2017-08-02 |
| Date Reported to Mfgr | 2017-08-02 |
| Date Mfgr Received | 2017-08-02 |
| Device Manufacturer Date | 2017-03-11 |
| Date Added to Maude | 2017-08-24 |
| 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 | MISS KELLY SPURGE |
| Manufacturer Street | 1/32 SILKWOOD RISE |
| Manufacturer City | CARRUM DOWNS, 3201 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3201 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MCCARTNEY TUBE |
| Generic Name | MCCARTNEY TUBE |
| Product Code | HEW |
| Date Received | 2017-08-24 |
| Model Number | 35-TV |
| Lot Number | 3522116 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SURGI SUPPLIES |
| Manufacturer Address | 3/29 MACQUARIE DRIVE THOMASTOWN, VICTORIA 2803 AS 2803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-08-24 |