MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for AUTO SUTURE OMS-T10SB manufactured by Us Surgical Puerto Rico.
[185806184]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185806185]
According to the reporter, during a laparoscopic totally extraperitoneal hernia repair, on inflation of the balloon the plastic cuff came off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2647580-2020-01147 |
| MDR Report Key | 9904499 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-06-28 |
| Date Added to Maude | 2020-03-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LISA HERNANDEZ |
| Manufacturer Street | 60 MIDDLETOWN AVE |
| Manufacturer City | NORTH HAVEN CT 06473 |
| Manufacturer Country | US |
| Manufacturer Postal | 06473 |
| Manufacturer Phone | 2034925563 |
| Manufacturer G1 | US SURGICAL PUERTO RICO |
| Manufacturer Street | 201 SABANETAS INDUSTRIAL PARK |
| Manufacturer City | PONCE PR 007164401 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 007164401 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTO SUTURE |
| Generic Name | LAPAROSCOPE, GENERAL & PLASTIC SURGERY |
| Product Code | GCJ |
| Date Received | 2020-03-31 |
| Model Number | OMS-T10SB |
| Catalog Number | OMS-T10SB |
| Lot Number | P9F1594Y |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | US SURGICAL PUERTO RICO |
| Manufacturer Address | 201 SABANETAS INDUSTRIAL PARK PONCE PR 007164401 US 007164401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-31 |