MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 1996-08-30 for STORZ CIRCLING BAND (240 STYLE) E5381 700 manufactured by Storz Instrument Co.
[20855]
Since implantation of these extra-ocular bands beginning in 4/96, five pts have suffered tremendous inflammatory reaction, restricted mobility and exophthalmos. The circling bands were explanted and the pts reimplanted with another circling band. On the sixth day there was the disappearance of pain and inflammation. The circling band was examined in the bacteriological department. No infections were found: the circling bands being used are of two different colors: one is blue and the other has a "yellow" shine. The bands with the blue shine were involved in the reported incdients.
Patient Sequence No: 1, Text Type: D, B5
[16495787]
Summarization of cytotoxicity tests are as follows: sample e5381-700 lot 261038345 identified as "blue" and "problem": grade/reactivity: 0/none, conclusion: not cytotoxic. Sample e5381-700 lot 149035276 identified as "yellow" and "no problem": grade/reactivity: 1/slight, conclusion: not cytotoxic. Sample e5381-700 part representing current inventory: grade/reactivity: 0/none, conclusion: not cytotoxic.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1920664-1996-00597 |
| MDR Report Key | 36890 |
| Report Source | 05,06 |
| Date Received | 1996-08-30 |
| Date of Report | 1996-08-02 |
| Date of Event | 1996-04-01 |
| Report Date | 1996-08-02 |
| Date Reported to Mfgr | 1996-08-02 |
| Date Mfgr Received | 1996-08-02 |
| Date Added to Maude | 1996-09-10 |
| 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 | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STORZ CIRCLING BAND (240 STYLE) |
| Generic Name | EXTRA OCULAR ORBITAL IMPLANT |
| Product Code | HQX |
| Date Received | 1996-08-30 |
| Model Number | NA |
| Catalog Number | E5381 700 |
| Lot Number | 261038345 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 38281 |
| Manufacturer | STORZ INSTRUMENT CO |
| Manufacturer Address | 3365 TREE COURT IND BLVD ST LOUIS MO 63122 US |
| Baseline Brand Name | STORZ CIRCLING BAND (240 STYLE) |
| Baseline Generic Name | EXTRA OCULAR ORBITAL IMPLANT |
| Baseline Model No | NA |
| Baseline Catalog No | E5381 700 |
| Baseline ID | NA |
| Baseline Device Family | RETINAL DETACHMENT IMPLANTS |
| Baseline Shelf Life Contained | A |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K832481 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-08-30 |