MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-08-07 for TRANS SPECULUM BLACK 2 3/4 MM * RN2575 manufactured by Integra Lifesciences.
[250152]
An ent surgeon mentioned that since 2/2002, he has been noticing that the trans-spenoidal speculum is tearing at the mucous membranes at the initiation of the procedure. Once the speculum is placed it functions as desired. The surgeon is inquiring if the lip of the speculum could be smaller to decrease the tearing of the mucous membranes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1121308-2002-00023 |
| MDR Report Key | 409144 |
| Report Source | 05,06 |
| Date Received | 2002-08-07 |
| Date of Report | 2002-08-05 |
| Date Mfgr Received | 2002-07-19 |
| Date Added to Maude | 2002-08-08 |
| 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 | JENNA KARABAS |
| Manufacturer Street | 311C ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362236 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRANS SPECULUM BLACK 2 3/4 MM |
| Generic Name | NON-POWERED SURGICAL INSTRUMENT |
| Product Code | EPY |
| Date Received | 2002-08-07 |
| Model Number | * |
| Catalog Number | RN2575 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 398155 |
| Manufacturer | INTEGRA LIFESCIENCES |
| Manufacturer Address | 105 MORGAN LANE PLAINSBORO NJ 08536 US |
| Baseline Brand Name | TRANS SPECULUM BLACK 2 3/4 |
| Baseline Catalog No | RN2575 |
| Baseline Device Family | NON-POWERED SURGICAL INSTRUMENT |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2002-08-07 |