MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-30 for CELLULOSE SPEARS 40-415-45A manufactured by .
[41759647]
Subconjunctival fragment of weckcell sponge. Suspect that sponge fragment broke off and adhered to blood clot/blocking it form view. It became apparent 2 weeks post-op when subconjunctival hemorrhage resolve. Fragment was removed successfully in the operating room without complications and patient has recovered uneventfully from both surgeries with good inter/outer pressure control. Staff complained that the weckcell (cellulose spears) fell apart. Second surgery required after discovery of the problem to remove fragment of cellulose. Manufacturer notified, product returned, and different brand of cellulose spear ordered. Persons involved: (b)(6).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5061423 |
| MDR Report Key | 5541639 |
| Date Received | 2016-03-30 |
| Date of Report | 2016-03-08 |
| Date of Event | 2016-01-07 |
| Date Added to Maude | 2016-04-01 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | CELLULOSE SPEARS |
| Generic Name | EYETEC |
| Product Code | HOZ |
| Date Received | 2016-03-30 |
| Returned To Mfg | 2016-03-09 |
| Catalog Number | 40-415-45A |
| Lot Number | 15EST0128 |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-03-30 |