MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-01-06 for VLOC 180 ESTCH ABS 2-0 6 LP VLOCA206L manufactured by United States Surgical A Division Of.
[2428401]
Procedure type: hysterectomy. According to the reporter: the surgeon attempted to pass the needle through tissue, the needle did not connect to the opposite side of the instrument leaving the needle in tissue and dislodged. There was no bleeding reported in excess of 250cc. The case was not extended by more than 30 mins. There was no unanticipated tissue loss. Additional info has been requested about the status of the needle.
Patient Sequence No: 1, Text Type: D, B5
[9534592]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1219930-2012-00017 |
| MDR Report Key | 2412841 |
| Report Source | 08 |
| Date Received | 2012-01-06 |
| Date of Report | 2011-12-12 |
| Date of Event | 2011-12-12 |
| Date Mfgr Received | 2011-12-12 |
| Date Added to Maude | 2012-04-09 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MELISSA ZAFFIN |
| Manufacturer Street | 60 MIDDLETOWN AVENUE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034927141 |
| Manufacturer Street | 195 MCDERMOTT RD. |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06473 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VLOC 180 ESTCH ABS 2-0 6 LP |
| Generic Name | DISPOSABLE SUTURING DEVICE |
| Product Code | MFJ |
| Date Received | 2012-01-06 |
| Catalog Number | VLOCA206L |
| Lot Number | V1G001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNITED STATES SURGICAL A DIVISION OF |
| Manufacturer Address | 195 MCDERMOTT RD. NORTH HAVEN CT 06473 US 06473 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-01-06 |