MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1999-09-29 for REINER-ALEXANDER EAR SYRINGE N0802 manufactured by Bausch & Lomb Surgical.
[21712844]
While using this item to irrigate the pt's ear, the tip came apart from the body of the syringe with such force, it ruptured the pt's ear drum. Surgery was required to repair the damage. No further adverse effect has been reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1932180-1999-00009 |
| MDR Report Key | 243403 |
| Report Source | 05,06 |
| Date Received | 1999-09-29 |
| Date of Report | 1999-09-01 |
| Date of Event | 1999-07-17 |
| Date Facility Aware | 1999-07-17 |
| Report Date | 1999-09-01 |
| Date Reported to Mfgr | 1999-09-01 |
| Date Mfgr Received | 1999-09-01 |
| Date Added to Maude | 1999-10-08 |
| 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 | 3 |
| Manufacturer Contact | JULI MOORE |
| Manufacturer Street | 3365 TREE CT INDUSTRIAL BLVD |
| Manufacturer City | ST. LOUIS MO 63122 |
| Manufacturer Country | US |
| Manufacturer Postal | 63122 |
| Manufacturer Phone | 6362263220 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REINER-ALEXANDER EAR SYRINGE |
| Generic Name | EAR SYRINGE |
| Product Code | KCP |
| Date Received | 1999-09-29 |
| Model Number | NA |
| Catalog Number | N0802 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 235812 |
| Manufacturer | BAUSCH & LOMB SURGICAL |
| Manufacturer Address | 3365 TREE CT INDUSTRIAL BLVD ST. LOUIS MO 63122 US |
| Baseline Brand Name | REINER-ALEXANDER EAR SYRINGE |
| Baseline Generic Name | EAR SYRINGE |
| Baseline Model No | NA |
| Baseline Catalog No | N0802 |
| Baseline ID | NA |
| Baseline Device Family | EAR SYRINGE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1999-09-29 |