MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2011-06-13 for GELITA-SPON/INVOTEC FINAL AS BRAND manufactured by Gelita Medical B.v..
[16725580]
A female in her (b)(6) presenting with facial pain and sinus polyp was treated at (b)(6), using gelita-spon/invotec final as an ent adhesion barrier. At three weeks post-op follow-up, the patient was found to have developed adhesions between the middle turbinate and lateral nasal wall. Patient will return to the operating room for revision and division of these adhesions. The same surgeon reports a further two (recent) cases of adhesions after middle meatal antrostomies and ethmoidectomy. For these two events, no further patient details, event details or patient outcomes were provided by the surgeon when requested.
Patient Sequence No: 1, Text Type: D, B5
[17039300]
Additional lot # r00008/1. Root cause of failure: at this time, no reason can be found as to why the device(s) should have failed to perform as intended for use as adhesion barriers. Gelita medical notes that all three reports are from one surgeon at one healthcare facility. Surgeon has indicated that they have been satisfied with the performance of this device in the past and will use this device in the future. Gelita medical will continue to monitor failure rates for this particular adverse event in this indication and for these lot numbers in particular.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005759666-2011-00001 |
| MDR Report Key | 2130421 |
| Report Source | 08 |
| Date Received | 2011-06-13 |
| Date of Report | 2011-06-10 |
| Date of Event | 2011-01-01 |
| Date Mfgr Received | 2011-05-13 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-06-21 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | OSDORPERWEG 590 |
| Manufacturer City | AMSTERDAM 1067SZ |
| Manufacturer Country | NL |
| Manufacturer Postal | 1067 SZ |
| Manufacturer Phone | 271842022 |
| Manufacturer G1 | GELITA AG |
| Manufacturer Street | UFERSTRASSE 7 |
| Manufacturer City | BERBACH 69412 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 69412 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GELITA-SPON/INVOTEC FINAL |
| Generic Name | ABSORBABLE GELATIN SPONGE |
| Product Code | KHJ |
| Date Received | 2011-06-13 |
| Model Number | AS BRAND |
| Lot Number | R00010/1 |
| Device Expiration Date | 2014-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GELITA MEDICAL B.V. |
| Manufacturer Address | OSDORPERWEG 590 AMSTERDAM 1067SZ NL 1067 SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2011-06-13 |