MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-04-28 for SERVICE REP, C/U,INTELIJET, 120V 4350H manufactured by Smith & Nephew, Inc.-endoscopy Div.
[178366]
Pump was set at approximately 60-70 milli-meters of mercury and was pumping at a much higher rate. The pt's shoulder became swollen and red. The pressure setting of the pump was dropped to approximately 20-30 milli-meters of mercury, but the unit continued to pump at a high rate. The surgery was completed with only a short delay. The pt did not experience any post-op injuries or complications. There was only a small amount of swelling in the shoulder.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1643264-2000-00018 |
| MDR Report Key | 276075 |
| Report Source | 07 |
| Date Received | 2000-04-28 |
| Date of Report | 2000-04-28 |
| Date of Event | 2000-03-30 |
| Date Added to Maude | 2000-05-04 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | STEVE JACKSON |
| Manufacturer Street | 3600 NW 138TH |
| Manufacturer City | OKLAHOMA CITY OK 73134 |
| Manufacturer Country | US |
| Manufacturer Postal | 73134 |
| Manufacturer Phone | 4059363000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SERVICE REP, C/U,INTELIJET, 120V |
| Generic Name | ARTHROSCOPIC IRRIGATION PUMP |
| Product Code | HRT |
| Date Received | 2000-04-28 |
| Model Number | 4350H |
| Catalog Number | 4350H |
| Lot Number | * |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267213 |
| Manufacturer | SMITH & NEPHEW, INC.-ENDOSCOPY DIV |
| Manufacturer Address | 160 DASCOMB RD ANDOVER MA 01810 US |
| Baseline Brand Name | SERVICE REP, C/U, INTELIJET, 120V |
| Baseline Generic Name | ARTHROSCOPIC IRRIGATION PUMP |
| Baseline Model No | 4350H |
| Baseline Catalog No | 4350H |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-04-28 |