MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2011-06-01 for IOWA PK PRESS PUNCH E3054 manufactured by Bausch & Lomb.
[2073738]
A report from a user facility in the (b)(4) was received stating: "defective. Missing the 2 tiers of the punch, which wasn't discovered until they were in the middle of the corneal transplant, which was aborted. " additional information received (b)(6) 2011 states "the patient had received standard sedation fentanyl and versed ivp (mac) only. The e3054 punch has 3 tiers to slide the trephines into. They placed trephine on top of punch and the bottom was gone. The doctor had made a slight incision in the patient's eye and stitched the incision. The patient was discharged home after recovering from sedation and will follow up with dr. (b)(6) to reschedule procedure. "
Patient Sequence No: 1, Text Type: D, B5
[9287332]
Visual inspection of the returned product noted one e3054 press punch was returned with the central platform (base), one spring activated and removable piston and two teflon blocks with red centers. The original packaging was not returned. Inspection of the assembly verified that the components were all present and assembled correctly. The customer was notified of the evaluation and subsequently the customer was provided instruction on the assembly design. The customer reported that understanding the design resulted in satisfaction with the device performance.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-2011-00045 |
| MDR Report Key | 2146934 |
| Report Source | 05 |
| Date Received | 2011-06-01 |
| Date of Report | 2011-05-04 |
| Date of Event | 2011-05-04 |
| Date Mfgr Received | 2011-05-04 |
| Date Added to Maude | 2011-08-05 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | SHARON TRELFORD, DIRECTOR |
| Manufacturer Street | 30 ENTERPRISE STE 450 |
| Manufacturer City | ALISO VIEJO CA 92656 |
| Manufacturer Country | US |
| Manufacturer Postal | 92656 |
| Manufacturer Phone | 9493891786 |
| Manufacturer Street | 3365 TREE CT. INDUSTRIAL BLVD. |
| Manufacturer City | ST. LOUIS MO 63122669 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63122 6694 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IOWA PK PRESS PUNCH |
| Product Code | HRH |
| Date Received | 2011-06-01 |
| Returned To Mfg | 2011-05-11 |
| Catalog Number | E3054 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2011-06-01 |