MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-11-16 for PRO TACK UNK manufactured by United States Surgical Corp..
[311653]
Patient underwent laparoscopic incisional hernia repair with dual mesh several months ago. Patient returned to surgery due to abdominal pain months later for laparoscopy and lysis of adhesions. The patient was found to have extensive adhesions along the left side of mesh which were densely adherent to the protack used to secure the mesh in place. There were no adhesions to the mesh itself.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 556120 |
| MDR Report Key | 556120 |
| Date Received | 2004-11-16 |
| Date of Report | 2004-11-09 |
| Date of Event | 2004-10-08 |
| Report Date | 2004-11-09 |
| Date Reported to FDA | 2004-11-16 |
| Date Added to Maude | 2004-11-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRO TACK |
| Generic Name | STAPLER |
| Product Code | ESX |
| Date Received | 2004-11-16 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | * |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 545792 |
| Manufacturer | UNITED STATES SURGICAL CORP. |
| Manufacturer Address | 195 MCDERMOTT RD. NORTH HAVEN CT 06473 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2004-11-16 |