MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-06-10 for BOWMAN LACRIMAL PROBES, SIZES 1 & 2 360273 manufactured by Integra York, Pa Inc..
[3553863]
Per customer medwatch (b)(4) received: lacrimal suction probe number plate broke off in scrubs hand. Unk if any injury, not indicated on form. Add'l info received (5/22/2013) from customer stating the procedure was removal of a foreign body-right foot. Device was used for gentle probing. No harm to pt, event occurred in the scrub technicians hand. No harm to scrub tech. Device will not be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[10782260]
The device involved in the reported incident is not available for eval. An investigation has been initiated based on the reported info.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2013-00028 |
| MDR Report Key | 3165149 |
| Report Source | 06 |
| Date Received | 2013-06-10 |
| Date of Report | 2013-06-10 |
| Date of Event | 2013-04-26 |
| Date Mfgr Received | 2013-05-14 |
| Date Added to Maude | 2013-06-17 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | SANDRA LEE |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer Country | US |
| Manufacturer Phone | 6099366826 |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BOWMAN LACRIMAL PROBES, SIZES 1 & 2 |
| Generic Name | NA |
| Product Code | HNL |
| Date Received | 2013-06-10 |
| Catalog Number | 360273 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-06-10 |