MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 1999-12-29 for HEALONID UNK manufactured by Pharmacia & Upjohn, Fyrislund.
[204581]
Endophthalmitis [eye infection not otherwise specified. ] case description: initial non-serious report rec'd 2 nov 99 was processed together with the follow-up report rec'd on 22 dec 99. This follow-up info upgraded the event to serious by adding the criteria of disability/incapacity. Four pts developed intraocular infection following intraocular lens implant surgery. The organisms cultured were different in the first three pts: (1) pseudomonas (2) staph. Aureus (3) coagulation negative. The results from the fourth pt is unknown three of these four pts (facility does not know which 3) rec'd healonid; the other opthalin plus (from ciba vision). The batch number of the healonid is known for one pt only and was af59062. One pt lost sight in the affected eye but facility does not know if this pt received healonid or opthalin. Co is unable to differentiate these 3 pts with the info provided. Suspect drug info - all possible products entered - patient will receive drug 1 or 4. Rptrs causality assessment-unlikely. Concomitant (suspect) medications used during surgery; balanced salt solution, lens opthalin, sodium hyaluronate. Case comment: eye infection is not listed in the core data sheet. In the present case, there is a temporal relation between the event and the administration of healonid, but the organisms cultured were different in the first three pts and results not yet available in the fourth. The event is assessed as unrelated to healonid. Surgical procedure and possibly concomitant medication offers a more probable explanation follow-up info regarding batch quality required.
Patient Sequence No: 1, Text Type: D, B5
[20244741]
Initial non-serious report received 11/2/1999 was processed together with the follow-up report received on 12/22/1999. This follow-up info upgraded the event to serious by adding the criteria disability/incapacity. Four pts developed intraocular infection following intraocular lens implant surgery. The organisms cultured were different in the first three pts: (1) psedomonas (2) staph, aurus (3) coagulation negative. The results from the fourth pt is uknown. Three of these four pt (do not know which 3) received helonid the other opthalin plus (from ciba vision). The batch number of the healonid is known for one pt only and was af59062. One of the pt lost sight in the affected eye but co does not know if this pt received healonid or opthalin. The info for cases 99-2514-s as (argus no 1999003132gb, 99-2515-s as (argus no 1999003139gb) and 99-2516-s as (argus no 1999003132gb, 99-2515-s as (argus no 1999003139gb) and 99-2516-s as (argus no 1999 003138gb) are as above. Co is unable to differentiate these 3 pts with the info provided. Suspect drug uinformation - all possible products entered - pt will received drug 1 or 4. Reporters causality assessment - unlikely. Concomitnat (suspect) medications use during surgery ; balanced salt solution, lens (surgical designs uk ltd) ophthalin, sodium hyaluronate (ciba vision). Follow-up 1/4/2000: results from review of batch documentation by the mfr. There are no other complaints reports received for the lot. No: af 59062. Case comment: eye infection is not listed in the core data sheet. In the present case there is a temporal relation between the event and the administration of healonid, but the organisms cultured were different in the first three pts and results not yet available in the fourth. The event is assessed as unrelated to healonid. Surgical procedure and possibly concomitant medication offers a more probable explanation. Follow-up info regarding batch quality required. Follow-up 1/4/2000: the results from the batch documentation by the mfr was received. No other complaint report was received for batch af59062. In 3 of the reported cases the batch number is unknown. In one of the 4 cases it is not known which viscoelastic was used. Since no further follow-up info is expected, a final report will be issued.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610566-1999-00039 |
| MDR Report Key | 257277 |
| Report Source | 01,05 |
| Date Received | 1999-12-29 |
| Date of Report | 1999-12-28 |
| Date Mfgr Received | 1999-12-21 |
| Date Added to Maude | 2000-01-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOACHIM VEITH, M.D. SR. DIRECTOR |
| Manufacturer Street | 7000 PORTAGE RD |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 6168338777 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEALONID |
| Generic Name | HYALURONATE SODIUM |
| Product Code | HQJ |
| Date Received | 1999-12-29 |
| Model Number | NA |
| Catalog Number | UNK |
| Lot Number | AF 59062 |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 249141 |
| Manufacturer | PHARMACIA & UPJOHN, FYRISLUND |
| Manufacturer Address | RAPSGATAN 7 UPPSALA SW SE-751 82 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 1999-12-29 |