MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2005-11-08 for SURGILAV PLUS HANDPIECE SET * 0207559000 manufactured by Stryker Instruments Puerto Rico.
[21623542]
The doctor noticed a black substance on his glove that was allegedly from the surgilav handpiece. An additional antibiotic was prescribed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2648666-2005-00068 |
| MDR Report Key | 645667 |
| Report Source | 07 |
| Date Received | 2005-11-08 |
| Date of Report | 2005-10-11 |
| Date of Event | 2005-10-06 |
| Date Mfgr Received | 2005-10-11 |
| Date Added to Maude | 2005-11-15 |
| 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 | 0 |
| Manufacturer Contact | JEN MARS |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 1269323770 |
| Manufacturer G1 | STRYKER INSTRUMENTS PUERTO RICO |
| Manufacturer Street | P O BOX 329 |
| Manufacturer City | ARROYO PR 00714 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00714 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SURGILAV PLUS HANDPIECE SET |
| Generic Name | IRRIGATION DEVICE |
| Product Code | EFS |
| Date Received | 2005-11-08 |
| Model Number | * |
| Catalog Number | 0207559000 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 635174 |
| Manufacturer | STRYKER INSTRUMENTS PUERTO RICO |
| Manufacturer Address | * ARROYO PR 00714 US |
| Baseline Brand Name | SURGILAV PLUS HANDPIECE SET |
| Baseline Generic Name | IRRIGATION DEVICE |
| Baseline Model No | * |
| Baseline Catalog No | 0207559000 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2005-11-08 |