MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2016-05-24 for STORZ INSTRUMENT ED7115 manufactured by Bausch + Lomb.
[45763367]
The device is not available for return; therefore a product evaluation will not be performed.
Patient Sequence No: 1, Text Type: N, H10
[45763368]
The user facility reported a patient in their care recently presented positive for a postoperative infection. As per their infection control policy and protocol, a notification is sent to all manufacturers whose products were used for surgery on (b)(6) 2016.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001920664-2016-00176 |
| MDR Report Key | 5675530 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2016-05-24 |
| Date of Report | 2016-05-05 |
| Date of Event | 2016-05-05 |
| Date Mfgr Received | 2016-05-05 |
| Date Added to Maude | 2016-05-24 |
| 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 | 3 |
| Manufacturer Contact | MS. SHARON SPENCER |
| Manufacturer Street | 50 TECHNOLOGY DRIVE WEST |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949398-569 |
| Manufacturer G1 | BAUSCH + LOMB |
| Manufacturer Street | 3365 TREE COURT INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Postal Code | 63122 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ INSTRUMENT |
| Generic Name | 27G CYSTOTOME SHORT |
| Product Code | HNY |
| Date Received | 2016-05-24 |
| Model Number | ED7115 |
| Lot Number | 04156016 |
| ID Number | NI |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BAUSCH + LOMB |
| Manufacturer Address | ROCHESTER NY 14609 US 14609 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-05-24 |