MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1997-02-20 for MEDPOR SURGICAL IMPLANT 13MM X 38MM X 6MM 6333 manufactured by Porex Surgical Inc..
[41043]
Material carved to nasal shape removed after two years due to recurring infection. Original date of surgery for implant was 5/22/95. Implanted at the base of the nose for smr (seroplasty). Pt was seen post operatively at one month and two months with no problems indicated. Pt was seen in 11/95, complaining that left columella was sligtly sore. No treatment recommended at this time. Pt was treated for a sinus infection in 2/1996 with antibiotics. 5/96, pt returned complaining of soreness in the right nasal base area (implant area) with puss visible from the implant site. Pt treated with 10 days of prednisone and z-pack (zethermax) for 3 weeks. 7/96, pt was seen with noticeable improvement, but still some secretion at floor of right nostril. After treatment with a 4th round of z-pack, antibiotics were discontinued to see if site would continue to heal on it's own. Pt was to return in 6 weeks for followup. Due to personal conflicts, pt did not return until 2/2/97, at which time she wanted the implant removed. 2/7/97, implant was removed. 2/11/97, pt seen, incision healing well with no visible draining. They will return the implant for investigation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1057129-1997-90001 |
| MDR Report Key | 71071 |
| Report Source | 05 |
| Date Received | 1997-02-20 |
| Date of Report | 1997-02-19 |
| Date of Event | 1997-02-07 |
| Date Mfgr Received | 1997-02-12 |
| Device Manufacturer Date | 1995-02-01 |
| Date Added to Maude | 1997-02-26 |
| 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 | MEDPOR SURGICAL IMPLANT |
| Generic Name | POROUS POLYETHYLENE BLOCK |
| Product Code | MBS |
| Date Received | 1997-02-20 |
| Model Number | 13MM X 38MM X 6MM |
| Catalog Number | 6333 |
| Lot Number | 01010195 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | * |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 70970 |
| Manufacturer | POREX SURGICAL INC. |
| Manufacturer Address | 4715 ROOSEVELT HIGHWAY COLLEGE PARK GA 30349 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1997-02-20 |